Evidence-Based Guidelines for Weaning and Discontinuing Ventilatory Support PDF
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2002
Neil R MacIntyre MD FAARC
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This document discusses evidence-based guidelines for weaning and discontinuing ventilatory support in medical patients. The guidelines cover various aspects of the process, including pathophysiology, assessment criteria, and management strategies.
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Special Articles Evidence-Based Guidelines for Weaning and Discontinuing Ventilatory Support A Collective Task Force Facilitated by the American College of Chest Physicians, the American Association for Respiratory Care, and the American College of Critical Care Medicine Introduction Pathophysiology...
Special Articles Evidence-Based Guidelines for Weaning and Discontinuing Ventilatory Support A Collective Task Force Facilitated by the American College of Chest Physicians, the American Association for Respiratory Care, and the American College of Critical Care Medicine Introduction Pathophysiology of Ventilator Dependence Criteria to Assess Ventilator Dependence Managing the Patient Who Has Failed a Spontaneous Breathing Test Role of Tracheotomy in Ventilator-Dependent Patients The Role of Long-Term Facilities [Respir Care 2002;47(1):69 –90] Introduction The discontinuation or withdrawal process from mechanical ventilation is an important clinical issue.1,2 Patients are generally intubated and placed on mechanical ventilators when their own ventilatory and/or gas exchange capabilities are outstripped by the demands placed on them from a variety of diseases. Mechanical ventilation also is required when the respiratory drive is incapable of initiating ventilatory activity, either because of disease processes or drugs. As the conditions that warranted placing the patient on the ventilator stabilize and begin to resolve, attention should be placed on removing the ventilator as The Writing Committee, on behalf of the Panel, includes Neil R MacIntyre MD FAARC (Chairman), Deborah J Cook MD, E Wesley Ely Jr MD MPH, Scott K Epstein MD, James B Fink MSc RRT FAARC, John E Heffner MD, Dean R Hess PhD RRT FAARC, Rolf D Hubmayr MD, and David J Scheinhorn MD. Other members of the panel include Suzanne Burns RN MSN CCRN RRN, David Chao MD, Andres Esteban MD, Douglas R Gracey MD, Jesse B Hall MD, Edward F Haponik MD, Marin H Kollef MD, Jordi Mancebo MD, Constantine A Manthous MD, Arthur S Slutsky MD, Meg A Stearn-Hassenpflug MS RD, and James K Stoller MD MSc FAARC. Reprinted with permission from Chest (Chest 2001;120(6)375–395). © American College of Chest Physicians. Copies can be ordered from the American College of Chest Physicians, at 1-800-343-2227 or 1-847-4981400. www.chestjournal.org. Correspondence: Neil R MacIntyre MD FAARC, Respiratory Care Services, Duke University Medical Center, Box 3911, Durham NC 27710. E-mail: [email protected]. RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 quickly as possible. Although this process often is termed “ventilator weaning” (implying a gradual process), we prefer the more encompassing term “discontinuation.” SEE THE RELATED EDITORIAL ON PAGE 29 Unnecessary delays in this discontinuation process increase the complication rate from mechanical ventilation (eg, pneumonia, airway trauma) as well as the cost. Aggressiveness in removing the ventilator, however, must be balanced against the possibility that premature discontinuation may occur. Premature discontinuation carries its own set of problems, including difficulty in reestablishing artificial airways and compromised gas exchange. It has been estimated that as much as 42% of the time that a medical patient spends on a mechanical ventilator is during the discontinuation process.3 This percent is likely to be much higher in patients with more slowly resolving lung disease processes. There are a number of important issues involved in the management of a mechanically ventilated patient whose disease process has begun to stabilize and/or reverse such that the discontinuation of mechanical ventilation becomes a consideration. First, an understanding of all the reasons that a given patient required a mechanical ventilator is needed. Only with this understanding can medical management be optimized. Second, assessment techniques to identify patients who are capable of ventilator discontinuation need to be utilized. Ideal assessment techniques should be able to easily and safely distinguish which pa- 69 EVIDENCE-BASED GUIDELINES Table 1. Grade A B C FOR WEANING Grades of Evidence Description Scientific evidence provided by well-designed, well-conducted, controlled trials (randomized and nonrandomized) with statistically significant results that consistently support the guideline recommendation Scientific evidence provided by observational studies or by controlled trials with less consistent results to support the guideline recommendation Expert opinion supported the guideline recommendation, but scientific evidence either provided inconsistent results or was lacking tients need prompt discontinuation and which need continued ventilatory support. Third, ventilator management strategies for stable/recovering patients who still require some level of ventilatory support need to be employed. These strategies need to minimize both complications and resource consumption. Fourth, extended management plans (including tracheotomy and long-term ventilator facilities) need to be considered for the long-term ventilator-dependent patient. To address many of these issues, the Agency for Healthcare Policy and Research (AHCPR) charged the McMaster University Evidence Based Practice Center to do a comprehensive evidence-based review of many of the issues involved in ventilator weaning/discontinuation. Led by Deborah Cook MD, an exhaustive review of several thousand articles in the world literature resulted in a comprehensive assessment of the state of the literature in 1999.4 At the same time, the American College of Chest Physicians (ACCP), the Society for Critical Care Medicine (SCCM), and the American Association for Respiratory Care (AARC) formed a task force to produce evidencebased clinical practice guidelines for managing the ventilator-dependent patient during the discontinuation process. The charge of this task force was to utilize the McMaster AHCPR report as well as their own literature review to address the following 5 issues: (1) the pathophysiology of ventilator dependence; (2) the criteria for identifying patients who are capable of ventilator discontinuation; (3) ventilator management strategies to maximize discontinuation potential; (4) the role of tracheotomy; and (5) the role of long-term facilities. Review/writing teams were formed for each of these issues. From these evidence-based reviews, a series of recommendations were developed by the task force, which are the basis of this report. Each recommendation is followed by a review of the supporting evidence, including an assessment of the strength of the evidence (Table 1). As there were many areas in which evidence was weak or absent, the expert opinion of the task force 70 AND DISCONTINUING VENTILATORY SUPPORT was relied on to “fill in the gaps.” Consensus was reached, first, by team discussions and, later, through the repeated cycling of the draft through all members of the task force. Both the McMaster AHCPR group and the task force recognized the needs for the future. These include more randomized controlled trials to look at a number of issues. Among the more important questions that need answering are the following: (1) Which criteria are the best indicators of reversal of respiratory failure in the screening process? (2) What factors are involved in ventilator dependence and which measurement techniques are most useful in determining ultimate success in the discontinuation process? (3) In balancing discontinuation aggressiveness against the risks of premature discontinuation, what is a reasonable reintubation rate in patients recently removed from ventilatory support? (4) What is the value of trying to reduce levels of partial ventilator support in stable/recovering patients who have failed a discontinuation assessment? (5) What role do tracheotomies have in facilitating the discontinuation process? (6) What is the role of the long-term facility, and when should patients be transferred to such facilities? Pathophysiology of Ventilator Dependence Introduction Patients require mechanical ventilatory support when the ventilatory and/or gas exchange capabilities of their respiratory system fail. This failure can be the result of processes both within the lung as well as in other organ systems, most notably the central nervous and the cardiovascular systems. Although patients may be dependent on ventilatory support for brief periods of anesthesia or neuromuscular blockade, the term “ventilator-dependent” is usually reserved for patients with a need for mechanical ventilation beyond 24 hours or by the fact that they have failed to respond during discontinuation attempts. Under these circumstances, the clinical focus should be not only on ventilator management but also should include a search for all of the possible reasons (especially potentially reversible ones) that may explain the ventilator dependency. Recommendation 1. In patients requiring mechanical ventilation for ⬎ 24 hours, a search for all the causes that may be contributing to ventilator dependence should be undertaken. This is particularly true in the patient who has failed attempts at withdrawing the mechanical ventilator. Reversing all possible ventilatory and nonventilatory issues should be an integral part of the ventilator discontinuation process. RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 EVIDENCE-BASED GUIDELINES Table 2. FOR WEANING Causes of Ventilator Dependency Causes Description Neurologic controller Respiratory system Central drive; peripheral nerves Mechanical loads: respiratory system mechanics; imposed loading Ventilatory muscle properties: inherent strength/endurance; metabolic state/nutrients/oxygen delivery and extraction Gas exchange properties: vascular properties and ventilation/perfusion matching Cardiac tolerance of ventilatory muscle work; peripheral oxygen demands Cardiovascular system Psychological issues Evidence (Grade B) There are a number of specific reasons why patients may be ventilator-dependent (Table 2). Determining which factor or factors may be involved in a given patient requires both clinical awareness of these factors as well as focused clinical assessments. The search for the underlying causes for ventilator dependence may be especially important if previously unrecognized, but reversible, conditions are discovered. Neurologic Issues: The ventilatory pump controller in the brainstem is a rhythm and pattern generator, which receives feedback from cortical, chemoreceptive and mechanoreceptive sensors. The failure of this controller can come from several factors.5–12 These factors can be either structural (eg, brainstem strokes or central apneas) or metabolic (eg, electrolyte disturbances or sedation/narcotic usage13,14). The failure of the peripheral nerves also can be the result of either structural factors15 or metabolic/drug factors.16,17 A unique neurologic dysfunction that also could cause ventilator dependence is obstructive sleep apnea, in which an artificial airway may be necessary to maintain airway patency.10,11 Respiratory System Muscle/Load Interactions: Often, patients who exhibit ventilator dependence do so because there appears to be a mismatch between the performance capacity of ventilatory pump and the load placed on it (ie, the capacity/load imbalance hypothesis).18 –23 There is ample evidence that ventilatory pump performance may be impaired in ventilator-dependent patients because ventilatory muscles are weak. This may be a consequence of atrophy and remodeling from inactivity.2,24 It may also be a consequence of injury from overuse and of insults associated with critical illness neuropathy and myopathy.25–29 A number of drugs (eg, neuromuscular blockers, aminoglycosides, and corticosteroids) also can contribute to myopathy,17,30 –32 as can various metabolic derangements (see RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 AND DISCONTINUING VENTILATORY SUPPORT below). Finally, dynamic hyperinflation can put ventilatory muscles in a mechanically disadvantageous position.33 In a number of studies, patients who failed to respond to a withdrawal from mechanical ventilation tended to be weaker (ie, they had a lower performance capacity) than those who succeeded,34 – 49 but, in general, the within-group variability in respiratory muscle strength was too large to justify general conclusions. Ventilatory muscle fatigue also could contribute to poor muscle performance. However, the role of fatigue in ventilator dependence is not well understood, and the studies performed to date21,26,50 –54 have failed to delineate the sensitivity and specificity of specific fatigue tests in ventilator-dependent patients. Ventilatory support reductionrelated changes in transdiaphragmatic pressure, respiratory rate, and thoracoabdominal dyssynchrony are clearly not specific manifestations of respiratory muscle fatigue.55– 60 The most promising diagnostic test of diaphragm contractility to date is the transdiaphragmatic pressure measurement during twitch stimulation of the phrenic nerves.21,61 However, too few patients have been studied with this technique to draw any meaningful conclusions about the prevalence of diaphragm fatigue that is attributable to ventilator dependence. The load on the ventilatory muscles is a function of ventilation demands and respiratory system mechanics (ie, primarily compliance and resistance). Normal minute ventilation during spontaneous breathing is generally ⬍ 10 L/min, normal respiratory system compliance (ie, tidal volume/static inflation pressure) is generally ⬎ 50 –100 mL/cm H2O, and normal airway resistance (ie, peak-static inflation pressure/constant inspiratory flow) is generally ⬍ 5–15 cm H2O/L/s. Ventilation demands can increase as a consequence of increased oxygen demands in patients with sepsis or increased dead space in patients with obstructive diseases. Compliance worsening can be a consequence of lung edema, infection, inflammation, or fibrosis, and of chest wall abnormalities such as edema or surgical dressings. Resistance worsening can be a consequence of bronchoconstriction and airway inflammation. Additional load can also be imposed by narrow endotracheal tubes and by insensitive or poorly responsive ventilator demand valves. The load imposed by ventilation demands interacting with respiratory system mechanics can be expressed as respiratory work, pressure time integral, or the change in metabolism (eg, the oxygen cost attributable to breathing). Many studies19,35,62– 66 show that patients who are ventilator-dependent tend to have larger respiratory muscle loads than do patients who can be withdrawn from mechanical ventilation. In patients with airways obstruction, the load imposed by dynamic hyperinflation has received particular attention as an important contributor to ventilator depen- 71 EVIDENCE-BASED GUIDELINES FOR WEANING dence.23,33,65,67–71 As is true for measures of ventilatory pump capacity, however, most investigators report considerable overlap in load parameters between patients with different discontinuation outcomes. Patients who go on to fail to respond to ventilator withdrawal attempts because of a capacity/load imbalance tend to display rapid, shallow breathing patterns.2,72,73 This pattern is advantageous from an energetics perspective, but it is also associated with increased dead space and wasted ventilation and, hence with impaired carbon dioxide elimination. Chemoreceptive and mechanoreceptive feedback into the neural control of breathing is not well understood, and thus it is difficult to distinguish whether this breathing pattern is a consequence of a reduced respiratory drive per breath or an inability of ventilatory muscles to respond to an appropriately increased neural stimulus.19,62,65,71,72 Metabolic Factors and Ventilatory Muscle Function: Nutrition, electrolytes, hormones, and oxygen transport are all metabolic factors that can affect ventilatory muscle function. Inadequate nutrition leads to protein catabolism and loss of muscle performance.74,75 The normal hypoxic ventilatory response and the hypercapnic ventilatory response also have been shown to deteriorate under conditions of semistarvation.76 In contrast, overfeeding also can impair the ventilator withdrawal process by leading to excess carbon dioxide production, which can further increase the ventilation loads on ventilatory muscles. Studies77,78 have suggested that proper nutritional support can increase the likelihood of success of ventilator withdrawal. A number of electrolyte imbalances also can impair ventilatory muscle function.5,9,79 – 81 Phosphate deficiency has been associated with respiratory muscle weakness and ventilator withdrawal failure. A study demonstrating improved transdiaphragmatic pressure values with the repletion of serum phosphorus levels in patients receiving mechanical ventilation, however, did not specifically address the issue of ventilator withdrawal.79 Magnesium deficiency also has been reported to be associated with muscle weakness,82 although the relationship to ventilator dependence has not been specifically addressed. Finally, bicarbonate excretion from inappropriate overventilation (often occurring in patients with chronic obstructive pulmonary disease (COPD) with chronic baseline hypercapnia) can impair ventilator withdrawal efforts as the patient has a diminished capacity to compensate for hypercapnia. Severe hypothyroidism and myxedema directly impair diaphragmatic function and blunt ventilatory responses to hypercapnia and hypoxia.83,84 Other hormonal factors that are important for optimal muscle function include insulin/glucagon and adrenal corticosteroids. As in other organs, adequate oxygen delivery and oxygen uptake by the ventilatory muscles is necessary for 72 AND DISCONTINUING VENTILATORY SUPPORT proper muscle function.85,86 Impaired oxygen delivery can be a consequence either of inadequate oxygen content or of inadequate cardiac output.87 Impaired oxygen uptake occurs most commonly during systemic inflammatory syndromes such as sepsis.88 Gas Exchange Factors: Gas exchange abnormalities can develop during ventilatory support reductions for several reasons. Various lung diseases produce ventilation-perfusion imbalances and shunts. Ventilator dependence thus may be a consequence of a need for high levels of expiratory pressure and/or the fraction of inspired oxygen (FIO2) to maintain an adequate oxygen content.5,9 A patient with hypoxemia also can develop a fall in mixed venous PO2 levels from the cardiovascular factors described below. Cardiovascular Factors: Several groups of investigators have drawn attention to cardiovascular responses in ventilator-dependent patients and have emphasized the potential for ventilatory support reductions to induce ischemia or heart failure in susceptible patients with limited cardiac reserve.9,89 –93 Putative mechanisms include the following: (1) increased metabolic demand and hence circulatory demands that are associated with the transition from mechanical ventilation to spontaneous breathing in patients with limited cardiac reserve; (2) increases in venous return as the contracting diaphragm displaces blood from the abdomen to the thorax; and (3) the increased left ventricular afterload that is imposed by negative pleural pressure swings. Lemaire and colleagues demonstrated left ventricular dysfunction (ie, the pulmonary capillary wedge pressure increased from 8 to 25 mm Hg) during failed ventilator withdrawal attempts in 15 patients with COPD. Following diuresis, 9 of these 15 patients were successfully withdrawn from the ventilator.90 Psychological Factors: Psychological factors may be among the most important nonrespiratory factors leading to ventilator dependence. Fear of the loss of an apparent life support system as well as social/familial/economic issues all may play a role. Stress can be minimized by frequent communication among the staff, the patient, and the patient’s family.94 Environmental stimulation using television, radio, or books also appears to improve psychological functioning.2 Ambulation using a portable ventilator (or bagging) has been shown to benefit attitudes and outlooks in long-term ventilator-dependent patients. Sleep deprivation may cause impairment of the respiratory control system,95 although this may be related to accompanying factors rather than to sleep deprivation per se.96 Finally, biofeedback may be helpful in decreasing the weaning time in patients who are having difficulty withdrawing from ventilatory support.97–98 RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 EVIDENCE-BASED GUIDELINES FOR WEANING Criteria to Assess Ventilator Dependence Introduction The process of discontinuing mechanical ventilatory support begins with a recognition of adequate recovery from acute respiratory failure. Thereafter, careful clinical assessments are required to determine the patient’s readiness for subsequent discontinuation of ventilatory support and, ultimately, extubation. To facilitate this process, investigators have focused on identifying objective criteria to determine the answers to the following questions: When can efforts to discontinue ventilation be initiated? What assessment strategies will best identify the patient who is ready for ventilator discontinuation? When should extubation be carried out, and how can extubation outcome best be predicted? Evidence to answer these questions comes largely from observational studies in which a certain parameter (or set of parameters) is compared in a group of patients who either successfully or unsuccessfully have been removed from the ventilator. The general goal of these studies is to find “predictors” of outcome. Evaluating the results from these types of studies can be difficult for several reasons. First, the “aggressiveness” of the clinician/investigator’s weaning and discontinuation philosophy needs to be understood, as it will affect the performance of a given predictor. A very aggressive clinical philosophy will maximize the number of patients withdrawn from ventilatory support but could also result in a number of premature discontinuations, with a subsequent need for reintubations and/or reinstitution of support. In contrast, a less aggressive clinical philosophy will minimize premature discontinuations but could also unnecessarily prolong ventilatory support in other patients. Unfortunately, there are no good data to help clinicians to determine the best balance between premature and delayed discontinuations in evaluating a given discontinuation strategy. Clearly, extubation failure should be avoided whenever possible because the need for reintubation carries an 8-fold higher odds ratio for nosocomial pneumonia99 and a 6-fold to 12-fold increased mortality risk.100 –103 In contrast, the maintenance of unnecessary ventilator support carries its own burden of patient risk for infection and other complications.104,105 Reported reintubation rates range from 4% to 23% for different intensive care unit (ICU) populations,100,101,103,104,106 –110 and may be as high as 33% in patients with mental status changes and neurological impairment.103 Although the optimal rate of reintubation is not known, it would seem likely to rest between 5% and 15%. Second, a number of methodological problems exist with most of these observational studies. For instance, patients are recruited into these studies because investigators believe that there is some reasonable chance of success for RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 AND DISCONTINUING VENTILATORY SUPPORT ventilator discontinuation. These “entry” criteria often include some form of clinical judgment or intuition, making results from one study difficult to compare to another. In addition, clinician/investigators deciding to proceed with ventilator discontinuation/extubation often have not been blinded to the parameters being analyzed as possible predictors. Indeed, the parameter being analyzed may often enter into the clinical decision on whether either to continue or to discontinue ventilatory support. Other methodological problems with these observational studies include different measurement techniques of a given parameter from study to study, large coefficients of variation with repeated measurements or from study to study of a given parameter,111,112 different patient populations (eg, longterm vs short-term ventilator dependence),113,114 and the absence of objective criteria to determine a patient’s tolerance for a trial of either discontinuation or extubation. Third, assessed outcomes differ from study to study. Some investigators have examined successful tolerance of a spontaneous breathing trial (SBT), others have used permanent discontinuation of the ventilator, and others have combined successful discontinuation and extubation. This latter approach is not optimal, given the differences in the pathophysiology of discontinuation versus extubation failure (see below).102,106 In addition, different studies use different durations of ventilator discontinuation or extubation to define success or failure. Although 24 – 48 hours of unassisted breathing often is considered to define the successful discontinuation of ventilator support, many studies use shorter time periods to indicate success and often do not report subsequent reintubation rates or the need to reinstitute mechanical ventilatory support. Fourth, a number of ways have been used to express predictor performance, and many can be confusing or misleading. Traditional indexes of diagnostic test power include sensitivity/specificity and positive/negative predictive values. These indexes are limited, however, in that they rely on a single cut point or threshold and that they do not provide an easy way to go from pretest likelihood or probability, through testing, to a posttest probability. The McMaster AHCPR report4 recommends the use of likelihood ratios (LRs), and these will be used in this report to describe predictor performance. The LR is an expression of the odds that a given test result will be present in a patient with a given condition compared to a patient without the condition. An LR ⬎ 1 indicates that the probability of success increases, while values ⬍ 1 indicate that the probability of failure increases. LRs between 0.5 and 2 indicate that a weaning parameter is associated with only small, clinically unimportant changes in the posttest probability of success or failure. In contrast LRs from 2 to 5 and from 0.3 to 0.5 correlate with small but potentially important changes in probability, while ratios of 5 to 10 or 0.1 to 0.3 correlate with more clinically important changes 73 EVIDENCE-BASED GUIDELINES Table 3. FOR WEANING Criteria Used in Weaning/Discontinuation Studies to Determine Whether Patients Receiving High Levels of Ventilatory Support Can Be Considered for Discontinuation (ie, Entered Into the Trials)* Objective Measurements Subjective Clinical Assessments Adequate oxygenation (eg, PO2 ⱖ 60 mm Hg on FIO2 ⱕ 0.4; PEEP ⱕ 5–10 cm H2O; PO2/FIO2 ⱖ 150–300) Stable cardiovascular system (eg, HR ⱕ 140 beats/min; stable blood pressure; no or minimal vasopressors) Afebrile (eg, temperature ⬍ 38°C) No significant respiratory acidosis Adequate hemoglobin (eg, Hgb ⱖ 8–10 g/dL) Adequate mentation (eg, arousable, GCS ⱖ 13, no continuous sedative infusions Stable metabolic status (eg, acceptable electrolytes) Resolution of disease acute phase; physician believes discontinuation possible; adequate cough PO2 ⫽ partial pressure of oxygen FIO2 ⫽ fraction of inspired oxygen PEEP ⫽ positive end-expiratory pressure HR ⫽ heart rate GCS ⫽ Glasgow Coma Scale *Adapted from References 101–103, 107–109, 119, and 120 in probability. Ratios of ⬎ 10 or ⬍ 0.1 correlate with very large changes in probability.115 Finally, because some investigators report data as continuous values (eg, means) rather than providing defined threshold values, combining studies using meta-analytic techniques often cannot be done. Recommendation 2. Patients receiving mechanical ventilation for respiratory failure should undergo a formal assessment of discontinuation potential if the following criteria are satisfied: 1. Evidence for some reversal of the underlying cause of respiratory failure; 2. Adequate oxygenation (eg, PaO2 /FIO2 ⬎ 150 –200; requiring positive end-expiratory pressure [PEEP] ⱕ 5– 8 cm H2O; FIO2 ⱕ 0.4 – 0.5) and pH (eg, ⱖ 7.25); 3. Hemodynamic stability as defined by the absence of active myocardial ischemia and the absence of clinically important hypotension (ie, a condition requiring no vasopressor therapy or therapy with only low-dose vasopressors such as dopamine or dobutamine ⬍ 5 g/kg/min); and 4. The capability to initiate an inspiratory effort. The decision to use these criteria must be individualized. Some patients not satisfying all of the above the criteria (eg, patients with chronic hypoxemia below the thresholds cited) may be ready for attempts at discontinuation of mechanical ventilation. 74 AND DISCONTINUING VENTILATORY SUPPORT Rationale and Evidence (Grade B) While some investigators argue that the process of discontinuation starts as soon as the patient is intubated, it would seem reasonable that an appropriate level of ventilatory support should be maintained until the underlying cause of acute respiratory failure and any complicating issues have shown some sign of reversal. Indeed, patients with unresolving respiratory failure who require high levels of ventilatory support are probably at high risk for respiratory muscle fatigue (and the consequent prolongation of the need for mechanical ventilation) if aggressive reductions in support are undertaken.50,52,116 –118 The criteria used by clinicians to define disease “reversal,” however, have been neither defined nor prospectively evaluated in a randomized controlled trial. Rather, various combinations of subjective assessment and objective criteria (eg, usually gas exchange improvement, mental status improvement, neuromuscular function assessments, and radiographic signs) that may serve as surrogate markers of recovery have been employed (Table 3).101–103,107–109,119,120 It should be noted, however, that some patients who have not ever met one or more of these criteria still have been shown to be capable of eventual liberation from the ventilator.104 These “clinical assessments” of the status of the patient’s respiratory failure, however, are not enough to make decisions on the discontinuation of support. For example, one survey121 of intensivists using clinical judgment to assess the potential for discontinuation found a sensitivity of only 35% (6 of 17 patients who were successfully discontinued were identified) and a specificity of 79% (11 of 14 who failed discontinuation were identified). Moreover, in 2 large trials,107,109 despite the presence of apparent disease stability/reversal prior to performing a screening SBT, the managing clinicians did not recognize that discontinuation was feasible in almost two thirds of the subjects. Thus, the conclusion is that some evidence of “clinical” stability/reversal is a key first step in assessing for discontinuation potential but that more focused assessments are needed before deciding to continue or discontinue ventilatory support. Recommendation 3. Formal discontinuation assessments for patients receiving mechanical ventilation for respiratory failure should be done during spontaneous breathing rather than while the patient is still receiving substantial ventilatory support. An initial brief period of spontaneous breathing can be used to assess the capability of continuing onto a formal SBT. The criteria with which to assess patient tolerance during SBTs are the respiratory pattern, adequacy of gas exchange, hemodynamic stability, and subjective comfort. The tolerance of SBTs lasting 30 to RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 EVIDENCE-BASED GUIDELINES Table 4. FOR WEANING AND DISCONTINUING VENTILATORY SUPPORT Measurements Performed Either While Patient Was Receiving Ventilatory Support or During a Brief Period of Spontaneous Breathing That Have Been Shown to Have Statistically Significant LRs to Predict the Outcome of a Ventilator Discontinuation Effort in More Than One Study Parameter Studies (n) Measured on Ventilator V̇E NIF PImax P0.1/PImax CROP score Measured During a Brief Period of Spontaneous Breathing RR VT f/VT ratio Threshold Values Positive LRs Range 20 10 16 4 2 10–15 L/min ⫺20 to ⫺30 cm H2O ⫺15 to ⫺30 cm H2O 0.30 13 0.81–2.37 0.23–2.45* 0.98–3.01 2.14–25.3 1.05–19.74 24 18 20 30–38 breaths/min 325–408 mL (4–6 mL/kg) 60–105/L 1.00–3.89 0.71–3.83 0.84–4.67 LR ⫽ likelihood ratio V̇E ⫽ minute ventilation *1 study reported a likelihood ratio (LR) of 35.79. NIF ⫽ negative inspiratory force (maximum inspiratory pressure) PImax ⫽ maximum inspiratory pressure P0.1 ⫽ mouth occlusion pressure 0.1 s after the onset of inspiratory effort CROP ⫽ index including compliance, respiratory rate, oxygenation, and pressure RR ⫽ respiratory rate VT ⫽ tidal volume f/VT ⫽ respiratory rate/tidal volume ratio Table 5. Frequency of Tolerating an SBT in Selected Patients and Rate of Permanent Ventilator Discontinuation Following a Successful SBT Study Patients Receiving SBT Patients Tolerating SBT n (%) Patients Discontinuing Ventilation Patients Having Ventilation Reinstituted n (%) Esteban et al105 Ely et al108 Dojat et al110 Esteban et al101 Esteban et al102 Esteban et al102 546 113 38 246 270* 256† 416 (76) 88 (78) 22 (58) 192 (78) 237 (89) 216 (84) 372 65 22 192 237 216 58 (16) 5 (4) 5 (23) 36 (19) 32 (14) 29 (13) SBT ⫽ spontaneous breathing trial *30 min SBT †120 min SBT 120 minutes should prompt consideration for permanent ventilator discontinuation. Rationale and Evidence (Grade A) Because clinical impression is so inaccurate in determining whether or not a patient meeting the criteria listed in Table 3 will successfully discontinue ventilatory support, a more focused assessment of discontinuation potential is necessary. These assessments can be performed either during spontaneous breathing or while the patient is still receiving substantial ventilatory support. These assessments can be used not only to drive decisions on weaning and discontinuation (ie, functioning as predictors) but also to offer insight into mechanisms of discontinuation failures. RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 The McMaster AHCPR report4 found evidence in the literature supporting a possible role for 66 specific measurements as predictors. Some of these (eg, the negative effects of the duration of mechanical ventilation, and the length of/difficulty of surgery44,122–124) were derived from general clinical observations, but most were from studies on focused assessments of the patient’s respiratory system. From these, the McMaster AHCPR group identified 8 parameters that had consistently significant LRs to predict successful discontinuation in several studies. Some of these measurements are made while the patient is still receiving ventilatory support; others require an assessment during a brief period of spontaneous breathing. These parameters, their threshold values, and the range of reported LRs are given in Table 4. It should be noted that despite the sta- 75 EVIDENCE-BASED GUIDELINES Table 6. FOR WEANING Criteria Used in Several Large Trials* to Define Tolerance of an SBT Objective measurements indicating tolerance/success Subjective clinical assessments indicating intolerance/failure Gas exchange acceptability (SpO2 ⱖ 85–90%; PO2 ⱖ 50–60 mm Hg; pH ⱖ 7.32; increase in PaCO2 ⱕ 10 mm Hg) Hemodynamic stability (HR ⬍ 120–140 beats/min; HR not changed ⬎ 20%; systolic BP ⬍ 180–200 mm Hg and ⬎ 90 mm Hg; BP not changed ⬎ 20%, no pressors required) Stable ventilatory pattern (eg, RR ⱕ 30–35 breaths/min, RR not changed ⬎ 50%) Change in mental status (eg, somnolence, coma, agitation, anxiety) Onset or worsening of discomfort Diaphoresis Signs of increased work of breathing (use of accessory respiratory muscles, thoracoabdominal paradox) SBT ⫽ spontaneous breathing trial SpO2 ⫽ oxygen saturation measured by pulse oximetry PO2 ⫽ partial pressure of oxygen PaCO2 ⫽ arterial partial pressure of carbon dioxide HR ⫽ heart rate RR ⫽ respiratory rate *References 101, 102, 105, 108–110, 119, and 120. tistical significance of these parameters, the generally low LRs indicate that the clinical applicability of these parameters alone to individual patients is low. Although assessments that are performed while a patient is receiving substantial ventilatory support or during a brief period of spontaneous breathing (Tables 3 and 4) can yield important information about discontinuation potential, assessments that are performed during a formal, carefully monitored SBT appear to provide the most useful information to guide clinical decision-making regarding discontinuation. Indeed, because of the efficacy and safety of a properly monitored SBT (see below), the assessments in Table 4 that are performed to predict SBT outcome are generally unnecessary. In concept, the SBT should be expected to perform well, as it is the most direct way to assess a patient’s performance without ventilatory support. Indeed, the evidence for this concept is quite strong. As can be seen in Table 5, multiple studies have found that patients tolerant of SBTs that are 30 to 120 min in length were found to have successful discontinuations at least 77% of the time. Because the 12 to 42% of patients in the Table 5 studies failing the SBT were not systematically removed from ventilatory support, the ability of a failed SBT to predict the need for ventilator dependence (ie, negative predictive 76 AND DISCONTINUING VENTILATORY SUPPORT value) cannot be formally assessed. Indeed, it is conceivable that iatrogenic factors such as endotracheal tube discomfort or continuous positive airway pressure (CPAP) demand-valve insensitivity/unresponsiveness, rather than true ventilator dependence, caused the failure of the SBT in at least some of these patients.125 Thus, it is thus unclear how many patients who are unable to tolerate an SBT would still be able to tolerate long-term ventilator discontinuation. Although the number is likely to be small, it is probably not zero, and this needs to be considered when dealing with patients who repeatedly fail an SBT. The criteria used to define SBT “tolerance” are often integrated indexes since, as noted above, single parameters alone perform so poorly. These integrated indexes usually include several physiologic parameters as well as clinical judgment, incorporating such difficult-to-quantify factors as “anxiety,” “discomfort,” and “clinical appearance.” The criteria that have been used in several large trials are given in Table 6. A potential concern about the SBT is safety. Although unnecessary prolongation of a failing SBT conceivably could precipitate muscle fatigue, hemodynamic instability, discomfort, or worsened gas exchange,19,50,117,126,127 there are no data showing that SBTs contribute to any adverse outcomes if terminated promptly when failure is recognized. Indeed, in a cohort of ⬎ 1,000 patients in whom SBTs were routinely administered and properly monitored as part of a protocol, only one adverse event was thought to be even possibly associated with the SBT.104 There is evidence that the detrimental effects of ventilatory muscle overload, if it is going to occur, often occurs early in the SBT.73,108,110,128 Thus, the initial few minutes of an SBT should be monitored closely, before a decision is made to continue (this is often referred to as the “screening” phase of an SBT). Thereafter, the patient should continue the trial for at least 30 min, but for not ⬎ 120 min,102 to assure maximal sensitivity and safety. It also appears that whether the SBT is performed with low levels of CPAP (eg, 5 cm H2O), low levels of pressure support (eg, 5–7 cm H2O), or simply as “T-piece” breathing has little effect on outcome.101,129 –131 CPAP, however, conceivably could enhance breath triggering in patients with significant auto-PEEP.132,133 Recommendation 4. The removal of the artificial airway from a patient who has successfully been discontinued from ventilatory support should be based on assessments of airway patency and the ability of the patient to protect the airway. Rationale and Evidence (Grade C) Extubation failure can occur for reasons distinct from those that cause discontinuation failure. Examples include upper airway obstruction or inability to protect the airway RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 EVIDENCE-BASED GUIDELINES FOR WEANING and clear secretions. The risk of postextubation upper airway obstruction increases with the duration of mechanical ventilation, female gender, trauma, and repeated or traumatic intubation.106 The detection of an air leak during mechanical ventilation when the endotracheal tube balloon is deflated can be used to assess the patency of the upper airway (cuff leak test).134 In a study of medical patients,135 a cuff leak ⬍ 110 mL (ie, average of 3 values on 6 consecutive breaths) measured during assist control ventilation within 24 hours of extubation identified patients at high risk for postextubation stridor. Although others have not confirmed the utility of the cuff leak test for predicting postextubation stridor,136 many patients who develop this can be treated with steroids and/or epinephrine (and possibly with noninvasive ventilation and/or heliox) and do not necessarily need to be reintubated. Steroids and/or epinephrine could also be used 24 hours prior to extubation in patients with low cuff leak values. It is also important to note that a low value for cuff leak may actually be due to encrusted secretions around the tube rather than to a narrowed upper airway. Despite this, reintubation equipment (including tracheostomy equipment) should be readily available when extubating patients with a low cuff leak values. The capacity to protect the airway and to expel secretions with an effective cough would seem to be vital for extubation success, although specific data supporting this concept are few. Successful extubations have been reported137 in a select group of brain-injured comatose patients who were judged to be capable of protecting their airways. However, it is difficult to extrapolate this experience to more typical ICU patients, and many would argue that some capability of the patient to interact with the care team should be present before the removal of an artificial airway. Airway assessments generally include noting the quality of cough with airway suctioning, the absence of “excessive” secretions, or the frequency of airway suctioning (eg, every 2 h or more).34,108,138 Coplin et al137 devised an “airway care score,” which semiquantitatively assesses cough, gag, suctioning frequency, and sputum quantity, viscosity, and character that predicted extubation outcome. Peak cough flows of ⬎ 160 L/min predict successful translaryngeal extubation or tracheostomy tube decannulation in neuromuscular- or spinal cord-injured patients.139 Managing the Patient Who Has Failed a Spontaneous Breathing Test Introduction The failure of a patient to complete an SBT raises 2 important questions. First, what caused the SBT failure, and are there readily reversible factors that can be corrected? Second, how should subsequent mechanical ven- RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 AND DISCONTINUING VENTILATORY SUPPORT tilatory support be managed? Specifically, should an SBT be tried again? If so, when? What form of ventilatory support should be provided in between SBTs and should support be at a constant high level or should efforts be made to routinely reduce the level of support gradually (ie, to wean support)? Evaluating evidence addressing mechanical ventilatory support strategies is particularly problematic. This is because trials comparing 2 or more approaches to ventilator management compare not only the modes of ventilation but also how those modes are used. Ideally, trial design should be such that management philosophies and the aggressiveness of support reduction are similar in each strategy being evaluated. Unfortunately, this is often not the case, as investigator experience with one approach has a tendency to result in more favorable “rules” of support reduction for that approach compared to others. Recommendation 5. Patients receiving mechanical ventilation for respiratory failure who fail an SBT should have the cause for the failed SBT determined. Once reversible causes for failure are corrected, and if the patient still meets the criteria listed in Table 3, subsequent SBTs should be performed every 24 hours. Rationale and Evidence (Grade A) Although failed SBTs are often a reflection of persistent respiratory system abnormalities,52 a failed SBT should prompt a search for other causes or complicating factors (see the “Patholophysiology of Ventilator Dependence” section). Specific issues include the adequacy of pain control, the appropriateness of sedation, fluid status, bronchodilator needs, the control of myocardial ischemia, and the presence of other disease processes that either can be readily addressed or else can be considered when deciding to proceed further with discontinuation attempts. Assuming medical management is optimized and that the patient who has failed an SBT still meets the criteria listed in Table 3, the following 2 questions involving subsequent SBTs arise: First, should SBTs be attempted again or should another approach to ventilator withdrawal be attempted? Second, if an SBT is attempted again, when should that be? There are some data on which to base an answer to the first question. The one large randomized trial107 that compared routine SBTs to 2 other weaning strategies that did not include SBTs provides compelling evidence that SBTs administered at least once daily shorten the discontinuation period compared to strategies that do not include daily SBTs. In addition, 2 studies108,119 showing the success of protocol-driven ventilator discontinuation strategies over “usual care” both included daily SBTs. The subsequent use of routine subsequent SBTs in this patient population thus seems appropriate. 77 EVIDENCE-BASED GUIDELINES FOR WEANING There are several lines of evidence that support waiting 24 hours before attempting an SBT again in these patients. First, except in patients recovering from anesthesia, muscle relaxants, and sedatives, respiratory system abnormalities rarely recover over a short period of hours and thus frequent SBTs over a day may not be expected to be helpful. Supporting this are data from Jubran and Tobin52 showing that failed SBTs often are due to persistent respiratory system mechanical abnormalities that are unlikely to reverse rapidly. Second, there are data suggesting that a failed SBT may result in some degree of respiratory muscle fatigue.50,117,118 If so, studies126,140 conducted in healthy subjects suggest that recovery may not be complete for anywhere from several hours to ⬎ 24 hours. Third, the trial by Esteban et al107 specifically addressed this issue and provided strong evidence that twice-daily SBTs offer no advantage over a single SBT and, thus, would serve only to consume unnecessary clinical resources. Recommendation 6. Patients receiving mechanical ventilation for respiratory failure who fail an SBT should receive a stable, nonfatiguing, comfortable form of ventilatory support. Rationale and Evidence (Grade B) There are a number of ventilator modes that can provide substantial ventilatory support as well as the means to reduce partial ventilatory support in patients who have failed an SBT (Table 7). A key question, however, is whether attempts at gradually lowering the level of support (weaning) offer advantages over a more stable, unchanging level of support between SBTs. The arguments for using gradual reductions are (1) that muscle conditioning might occur if ventilatory loads are placed on the patient’s muscles and (2) that the transition to extubation or to an SBT might be easier from a low level of support than from a high level of support. Data supporting either of these claims, however, are few. However, maintaining a stable level of support between SBTs reduces the risk of precipitating ventilatory muscle overload from overly aggressive support reduction. It also offers a substantial resource consumption advantage in that it requires far less practitioner time. The study by Esteban et al107 partially addressed this issue in that it compared daily SBTs (and a stable level of support in those who failed) to 2 other approaches using gradual reductions in support (ie, weaning with pressure support or intermittent mandatory ventilation [IMV]) and demonstrated that the daily SBT with stable support between tests permitted the most rapid discontinuation. What has not been addressed, however, is whether gradual support reductions coupled with daily SBTs offer any advantages. The McMaster AHCPR report4 identified 3 other randomized trials109,141,142 that compared gradual reduction 78 AND DISCONTINUING VENTILATORY SUPPORT Table 7. Modes of Partial Ventilator Support Mode SIMV PSV SIMV ⫹ PSV VS VAPS(PA) MMV APRV Patient Work Adjusted By Number of machine breaths supplied (ie, the fewer the number of machine breaths, the more spontaneous breaths are required) Level of inspiratory pressure assistance with spontaneous efforts Combining the adjustments of SIMV and PSV PSV with a “guaranteed” minimum VT (PSV level adjusts automatically according to clinician VT setting) PSV with “guaranteed” minimum VT (additional flow is supplied at end inspiration if necessary to provide clinician VT setting) SIMV with a “guaranteed” V̇E (machine breath rate automatically adjusts according to clinician V̇E setting) Pressure difference between inflation and release (ie, the less the pressure difference, the more spontaneous breaths are required) SIMV ⫽ synchronized intermittent mandatory ventilation PSV ⫽ pressure support ventilation VS ⫽ volume support VAPS(PA) ⫽ volume-assured pressure support (pressure augmentation) VT ⫽ tidal volume MMV ⫽ mandatory minute ventilation V̇E ⫽ minute ventilation APRV ⫽ airway pressure-release ventilation strategies using different modes but not routine daily SBTs. The study by Brochard et al109 was the most similar in design to the study by Esteban et al107 that was noted before, and it included a pressure-support group and an IMV group. A third group received gradually increasing fixed periods of spontaneous breathing that were designed only to provide brief periods of work and not specifically to test for discontinuation (ie, they were not routine daily SBTs, as defined above). The results showed that their use of gradually lengthening spontaneous breathing periods was inferior to other strategies and, like the Esteban trial, the pressure support strategy was easier to reduce than the IMV strategy. The other 2 randomized trials141,142 that were identified by the McMaster AHCPR report were much smaller than the Esteban et al107 and Brochard et al,109 and both suggested that pressure support was easier to reduce than IMV alone. Because none of these studies offer evidence that gradual support strategies are superior to stable support strategies between SBTs, the clinical focus for the 24 hours after a failed SBT should be on maintaining adequate muscle unloading, optimizing comfort (and thus sedation needs), and avoiding complications, rather than aggressive ventilatory support reduction. Ventilator modes and settings can affect these goals.143 Assisted modes of ventilation (as opposed to machinecontrolled modes) are generally preferable in this setting RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 EVIDENCE-BASED GUIDELINES FOR WEANING because they allow patient muscle activity and some patient control over the ventilatory pattern. Although good clinical supporting data are lacking, these features may help to avoid muscle disuse atrophy24 and may reduce sedation needs in these types of patients.143 With assisted modes, sensitive/ responsive ventilator triggering systems,144 –147 applied PEEP in the presence of a triggering threshold load from autoPEEP,132,133 flow patterns matched to patient demand,148 –152 and appropriate ventilator cycling to avoid air trapping153,154 are all important to consider in achieving patient comfort and minimizing imposed loads. In recent years, several ventilator support modes (volume support,155 adaptive support ventilation (ASV),155,156 minimum minute ventilation (MMV),155 and a knowledgebased system for adjusting pressure support110,157) have been developed in an attempt to “automatically” wean patients by feedback from one or more ventilator-measured parameters. Minimum minute ventilation set at either 75% of measured minute ventilation158 or to a carbon dioxide target,120 and a knowledge-based system for adjusting pressure support110,157 all have been shown to be capable of automatically reducing support safely in selected populations. However, none of these has been compared to the daily SBT approach described above. Moreover, the premises underlying some of these feedback features (eg, that an ideal volume can be set for volume support or that an ideal ventilatory pattern based on respiratory system mechanics can be set for ASV) may be flawed, especially in sick patients. Indeed, potentially flawed feedback logic may, in fact, delay support reduction. Further work is clearly needed to establish the role (if any) of these automated approaches. There has been increasing interest in the use of noninvasive positive-pressure ventilation (NPPV) in recent years. Although NPPV has been used primarily as a method to avoid intubation, it has also been used as a technique to facilitate the discontinuation of invasive ventilatory support. Data from the pooling of results of 2 prospective, randomized controlled trials159,160 in patients with chronic respiratory disease suggest the need for reductions in the durations of mechanical ventilation, ICU stay, mortality, and the incidence of nosocomial pneumonia with postextubation support provided by NPPV. Appropriate patient selection and the feasibility of the widespread application of these findings remains to be determined. Recommendation 7. Anesthesia/sedation strategies and ventilator management aimed at early extubation should be used in postsurgical patients. Rationale and Evidence (Grade A) The postsurgical patient poses unique problems for ventilator discontinuation. In these patients, depressed respi- RESPIRATORY CARE • JANUARY 2002 VOL 47 NO 1 AND DISCONTINUING VENTILATORY SUPPORT ratory drive and pain issues are the major reasons for ventilator dependence. Optimal sedation, pain management, and ventilator strategies offer opportunities to shorten the duration of mechanical ventilation. The McMaster AHCPR report4 identified 5 randomized controlled trials in postcardiac surgery patients161–165 that demonstrated that a lower anesthetic/sedation regimen permitted earlier extubation. The pooled results showed a mean effect of 7 hours. Similar effects were found using these approaches in other postsurgical populations.166 –170 Ventilator modes that guarantee a certain breath rate and minute ventilation (assist control modes, IMV, and MMV) are important in patients with unreliable respiratory drives. However, frequent assessments and support reductions are necessary since recovery in these patients usually occurs over only a few hours. Aggressive support reduction strategies have been shown to lead to earlier discontinuations of ventilation.166,169 Conceptually, the immediate postoperative patient might be ideally suited for simple automatic feedback modes that provide a backup form of support (eg, MMV or ASV).120,156,158 Data showing improved outcomes or lower costs with these automated approaches, however, are lacking. Recommendation 8. Weaning/discontinuation protocols designed for nonphysician health care professionals (HCPs) should be developed and implemented by ICUs. Protocols aimed at optimizing sedation should also be developed and implemented. Rationale and Evidence (Grade A) There is clear evidence that nonphysician HCPs (eg, respiratory therapists and nurses) can execute protocols that enhance clinical outcomes and reduce costs for critically ill patients.171 In recent years, 3 randomized controlled trials incorporating 1,042 patients also have demonstrated that outcomes for mechanically ventilated patients who were managed using HCP-driven protocols were improved over those of control patients managed with standard care. Specifically, Ely et al108 published the results of a 2-step protocol driven by HCPs using a daily screening procedure followed by an SBT in those who met screening criteria. The discontinuation of mechanical ventilation was then recommended for patients tolerating the SBT. Although the 151 patients managed with the protocol had a higher severity of illness than the 149 control subjects, they were removed from the ventilator 1.5 days earlier (with 2 days less weaning), had 50% fewer complications related to the ventilator, and had mean ICU costs of care that were lower by ⬎ $5,000 per patient. In a slightly larger trial with a more diverse patient population, Kollef et al119 used 3 different nonphysician-HCP-driven protocols and showed that the mean duration of mechanical 79 EVIDENCE-BASED GUIDELINES FOR WEANING ventilation could be reduced by 30 hours. Finally, Marelich et al172 showed that the duration of mechanical ventilatory support could be reduced almost 50% using nurse-driven and therapist-driven protocols (p ⫽ 0.0001). The reproducibility of benefit for using various protocols in different ICUs and institutions suggests that it is the use of a standardized approach to management rather than any specific modality of ventilator support that improves outcomes. Indeed, when other key features in the management of mechanically ventilated patients, such as sedation and analgesia, also are subjected to protocols, further reductions in the time spent receiving mechanical ventilation can be achieved. For example, in a randomized controlled trial173 of a nursing-implemented sedation protocol for 321 patients receiving mechanical ventilation, the use of the protocol was associated with a 50% reduction in the duration of mechanical ventilation and 2-day and 3-day reductions in the median ICU and lengths of hospital stay, respectively (all p values ⬍ 0.01). More recently, Kress et al174 published the results of a randomized controlled trial of 128 patients showing that a daily spontaneous awakening trial was associated with 2 days fewer spent receiving mechanical ventilation (p ⫽ 0.004) and a 3-day shorter ICU stay (p ⫽ 0.02). The data do not support endorsing any one ventilator discontinuation protocol, and the choice of a specific protocol is best left to the individual institution. In designing these protocols, consideration should be given to other recommendations in this document as well as to the specific patient populations. For instance, medical patients with severe lung injury might benefit from one type of management strategy (see recommendations 2 to 5), whereas surgical patients recovering from anesthesia might benefit from another strategy (see recommendation 7). In the context of emerging data about the benefits of NPPV159,160 and the substantial roles of HCPs in providing this treatment, there should be efforts made to develop HCP-driven