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(Chest. 2001;120:454S-463S.)
© 2001 American College of Chest Physicians

Mechanical Ventilator Weaning Protocols Driven by Nonphysician Health-Care Professionals*

Evidence-Based Clinical Practice Guidelines

E. Wesley Ely, MD, MPH, FCCP; Maureen O. Meade, MD, MSc; Edward F. Haponik, MD, FCCP; Marin H. Kollef, MD, FCCP; Deborah J. Cook, MD, MSc; Gordon H. Guyatt, MD, MSc and James K. Stoller, MD, FCCP

* From the Departments of Medicine (Dr. Ely), Vanderbilt University School of Medicine, Nashville, TN; the John Hopkins University School of Medicine (Dr. Haponik), Baltimore, MD; Barnes-Jewish Medical Center and Washington University School of Medicine (Dr. Kollef), St. Louis, MO; the Cleveland Clinic Foundation (Dr. Stoller), Cleveland, OH; and the Evidence-Based Practice Center (Drs. Meade, Cook, and Guyatt), McMaster University, Hamilton, Ontario, Canada. This research was supported by National Institutes of Health grant No. AG01023-01A1 (EWE) and a Beeson Scholarship from the American Federation for Aging Research (EWE).

Correspondence to: E. Wesley Ely, MD, MPH, FCCP, Division of Allergy/Pulmonary/Critical Care Medicine, Center For Health Services Research, Sixth Floor Medical Center East, Vanderbilt University Medical Center, Nashville, TN 37232-8300; e-mail: wes.ely{at}mcmail.vanderbilt.edu


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Health-care professionals (HCPs) can provide protocol-based care that has a measurable impact on critically ill patients beyond their liberation from mechanical ventilation (MV). Randomized controlled trials have demonstrated that protocols for liberating patients from MV driven by nonphysician HCPs can reduce the duration of MV. The structure and features of protocols should be adapted from published protocols to incorporate patient-specific needs, clinician preferences, and institutional resources. As a general approach, shortly after patients demonstrate that their condition has been stabilized on the ventilator, a spontaneous breathing trial (SBT) is safe to perform and is indicated. Ventilator management strategies for patients who fail a trial of spontaneous breathing include the following: (1) consideration of all remediable factors (such as electrolyte derangements, bronchospasm, malnutrition, patient positioning, and excess secretions) to enhance the prospects of successful liberation from MV; (2) use of a comfortable, safe, and well-monitored mode of MV (such as pressure support ventilation); and (3) repeating a trial of spontaneous breathing on the following day. For patients who pass the SBT, the decision to extubate must be guided by clinical judgment and objective data to minimize the risk of unnecessary reintubations and self-extubations. Protocols should not represent rigid rules but, rather, guides to patient care. Moreover, the protocols may evolve over time as clinical and institutional experience with them increases. Useful protocols aim to safely and efficiently liberate patients from MV, reducing unnecessary or harmful variations in approach.

Key Words: analgesics • artificial respiration • clinical protocols • critical care • ICU • mechanical ventilation • outcomes • respiratory insufficiency • respiratory therapy • sedation • sedatives • ventilator weaning


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Many advances have been made regarding the optimal methods of weaning ventilatory support and liberating patients from the ventilator. These efforts are important because mechanical ventilation (MV) is associated with considerable morbidity, mortality, and costs.1 2 3 However, the premature discontinuation of MV can contribute to the incidence of failed extubation, nosocomial pneumonia, or increased mortality.4 5 6 Traditionally, physicians have approached the discontinuation of MV through a gradual reduction in ventilatory support, which is reflected in universally applied but varying forms of "weaning." However, this gradual approach may unnecessarily delay the extubation of patients who have recovered from respiratory failure. With better recognition of the complications of MV, and with increasing awareness of the resources consumed during the care of patients experiencing respiratory failure, a change in the culture of weaning is well-supported by the literature. Evidence supports the current concept of "liberation" from MV 7 8 9 (ie, that the timely recognition of recovery from respiratory failure is more important than the manipulation of MV in an attempt to facilitate weaning). Furthermore, utilizing the skills and expertise of nonphysician health-care professionals (HCPs) can improve patient outcomes.

The McMaster University Evidence-Based Practice Center has conducted a comprehensive review of the literature regarding weaning to address key questions posed by the Agency for Health Care Policy and Research (AHCPR).1 To create this 380-page document, which reviewed approximately 1,000 articles from 1971 to 2000, the authors chose 154 articles for final review and evaluation. Among the many aspects of weaning reviewed by the McMaster-AHCPR investigators, the strongest conclusions were drawn in regard to the development and implementation of ventilator weaning protocols and the use of nonphysician HCPs (eg, respiratory-care practitioners [RCPs] and nurses) in the ICUs to enhance patients’ liberation from MV.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
We have described the methods of our reviews in the introduction to this supplement and in the article concerning alternative discontinuation assessment methods and weaning modes. Herein, we summarize these methods briefly, focusing on aspects specific to this topic.

Eligibility Criteria
We included all studies of adult patients who were receiving MV that compared weaning conducted according to an explicit protocol to the traditional, physician-directed approach. We included randomized trials, or controlled nonrandomized studies. We excluded studies that reported physiologic outcomes exclusively.

Search for Relevant Studies
To identify relevant studies, we searched MEDLINE, EMBASE, HEALTHStar, CINAHL, the Cochrane Controlled Trials Registry, and the Cochrane Data Base of Systematic Reviews from 1971 to September 1999, and we examined the reference lists of all included articles for other potentially relevant citations.

Data Abstraction and Assessment of Methodological Quality
Five respiratory therapists and five intensivists participated in data abstraction and in rating the methodological quality of all eligible randomized trials or nonrandomized controlled cohort studies that addressed treatment issues. One of the investigators rechecked the final data abstraction. The methodological features of randomized trials that we abstracted included the following: the method of randomization and whether randomization was concealed; the extent to which groups were similar with respect to important prognostic factors; whether investigators conducted an intention-to-treat analysis; whether patients, clinicians, and those assessing outcome were blind to allocation; the extent to which the groups received similar cointerventions; and reporting of the reasons for study withdrawal. For nonrandomized controlled clinical trials, we considered the extent to which groups were similar with respect to important prognostic factors, whether the investigators adjusted for differences in prognostic factors, and the extent to which the groups received similar cointerventions.

Statistical Analysis
We abstracted or, when necessary, calculated effect sizes in terms of relative risks (RRs) and associated 95% confidence intervals (CIs) for binary outcomes and mean differences and 95% CIs for continuous variables.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
We identified four randomized controlled trials (RCTs) that compared protocol-based weaning to conventional weaning (Table 1 ).9 10 11 12 One very small trial10 (15 patients) compared computer-directed weaning to physician-directed weaning and found trends in favor of the computer-directed weaning in both nonextubation and reintubation rates (Table 2 ).


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  		Table 1. Characteristics of RCTs Comparing Weaning Protocols to Physician-Directed Weaning*

 

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  		Table 2. Results of Individual RCTs Comparing Weaning Protocols to Physician-Directed Weaning*

 
Three RCTs9 11 12 compared weaning protocols that were largely implemented by RCPs and nurses to conventional physician-directed weaning. These trials were all methodologically strong (Table 1) and, for this field, very large (300 to 357 patients). All three studies enrolled virtually all patients who were receiving MV in the participating units during the study periods.

Ely and colleagues9 reported a two-step protocol that was driven by nurses and RCPs incorporating daily screening followed by a spontaneous breathing trial (SBT). Although the 151 patients who were managed in the medical and coronary ICUs and were in the intervention group had a higher severity of illness than the 149 control patients, they were removed from the ventilator 1.5 days earlier, had 2 fewer days of weaning, had 50% fewer complications related to the ventilator, and had mean ICU costs of care that were lower by more than $5,000 lower per patient.9 These investigators studied patients whose median durations of MV were 4.5 and 6 days, respectively, in the protocol-directed and physician-directed groups. The RR of successful extubation in the protocol-directed group was 2.13 (95% CI, 1.55 to 2.92; p < 0.001), indicating that MV was successfully discontinued sooner in the protocol-directed group than in the control group. The largest separation between groups was at approximately 5 days, and differences disappeared by about 15 days. Patients in the physician-directed group spent a day longer in the ICUs and 1.5 days longer in the hospital. Neither of these differences reached statistical significance.

Kollef and colleagues11 conducted their study in four ICUs using three different weaning protocols that had been developed and tested by the ICU staff prior to the start of the study. Despite the large sample size, the power of their study to detect differences in key end points was limited by the fact that most patients spent a relatively short period of time on the ventilator. In the protocol-directed and physician-directed groups, 25% of the patients were extubated by 15 and 21 h, respectively, 50% were extubated by 35 and 44 h, respectively, and 75% were extubated by 114 and 209 h, respectively. Only 12% and 17%, respectively, of the patients spent > 7 days on the ventilator. Survival and regression analyses suggested a difference that favored patients in the protocol group. Simple analyses also favored the protocol-directed group, but they failed to reach statistical significance (Table 2) .

In a more recent investigation that included 335 patients (approximately 50% surgical, and predominantly trauma), Marelich and colleagues12 showed in an RCT that the use of a weaning protocol incorporating multiple daily SBT assessments shortened the median duration of MV from 124 to 68 h (p = 0.001). Investigators censored patients in the protocol group for whom attending physicians violated the protocol, potentially excluding from the analysis patients who were destined to wean more slowly from ventilation. This may overestimate the reported benefit of the weaning protocol with respect to the duration of ventilation; thus, these results are potentially misleading.

In addition to these RCTs, 11 non-RCTs have examined the impact of, largely, respiratory therapist-directed or nursing-directed weaning compared to physician-directed weaning on weaning outcomes in critically ill patients (Tables 3 4 4A ).13 14 15 16 17 18 19 20 21 These studies, conducted in a variety of populations, are generally much larger than the corresponding RCTs but are more prone to bias, given their observational design (Table 3) . The results of these nonrandomized studies are generally consistent with the results of the RCTs, demonstrating statistically significant reductions or trends toward reductions in the duration of MV and ICU length of stay. Protocol-based weaning was associated with other favorable process-of-care outcomes such as fewer arterial blood gas analyses. Mortality and reintubation rates did not appear to differ between the experimental and control groups. Complications of protocol-based weaning were not reported.


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  		Table 3. Characteristics of Clinical Non-RCTs Comparing Weaning Protocols to Physician-Directed Weaning*

 

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  		Table 4. Results of Individual Clinical Non-RCTs Comparing Weaning Protocols to Physician-Directed Weaning*

 

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  		Table 4A. Continued

 

   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
To provide clinicians with the most useful information set for the design and implementation of weaning protocols, we have structured this section into seven key recommendations (Table 5 ). The results of the foregoing evidence-based review were incorporated into the first three recommendations. The last four recommendations were derived from emerging data about weaning from MV and extubation, the optimal delivery of sedation and analgesia in the ICU, and the need for an objective and graded plan of implementation.


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  		Table 5. Summary of Recommendations for MV Weaning Protocols*

 
Respiratory Care Provided by Nonphysician HCPs
Considerable evidence exists that allied HCPs can implement respiratory-care protocols that enhance clinical outcomes for critically ill patients with respect to appropriate blood gas analysis or chest physiotherapy.21 22 23 24 25 26 Respiratory-care protocols (ie, therapist-driven or patient-driven protocols) have been investigated extensively during the past few years.27 28 29 30 31 From these studies, we have learned that the use of protocols can improve clinical outcomes and enhance the appropriate allocation of respiratory-care services.

Recommendation 1: Based on evidence from randomized trials, we recommend that nonphysician HCPs be included in the development and utilization of respiratory-care protocols (not confined to liberation from MV).

Weaning Protocols
The McMaster evidence-based AHCPR report on weaning1 concluded that there is strong evidence that weaning protocols can, under some circumstances, decrease the length of time that a patient spends on the ventilator. These protocols may be organized and led by physician opinion leaders, then implemented on a daily basis by nonphysician HCPs. A major transition in thought regarding weaning began in 1994 and 1995, when it was demonstrated for the first time in RCTs,8 32 that one modality of weaning might be superior to another if it was executed in a specified fashion. However, these data did not establish that a weaning protocol was superior to the standard of care, which was the individual physician’s best management.33 Now, the results of three randomized trials,9 11 12 including 992 patients, suggest that protocols can, at least under some circumstances, result in important decreases in the duration of MV. The implementation of nurse-driven or RCP-driven weaning protocols, regardless of the specific weaning mode employed, can significantly expedite safe liberation from MV.1 31

That three RCTs using appreciably different protocols have all demonstrated statistically significant reductions in the time spent receiving MV (although the magnitude of the difference between groups varied substantially) suggests that it is the protocols (and the culture change that these protocols represent) that effect the benefit, rather than any specific modality of weaning. The current data do not support the use of any one protocol (although some guidelines are offered below), and the selection of an appropriate protocol is best left to multidisciplinary teams at individual institutions. Importantly, each institution must endorse the fiscal commitment and the staffing modifications that are necessary for developing and implementing a multidisciplinary weaning protocol team of dedicated HCPs.34 While institutions should embrace collaborative weaning efforts35 and should customize protocols to local practices, several important general concepts may ease the process of implementation and may enhance success, and these are reviewed in multiple sections below.

Recommendation 2: Based on evidence from RCTs, we recommend that ICU clinicians utilize protocols for liberating patients from MV in order to safely reduce the duration of MV.

SBTs
Given the low negative predictive value of most weaning parameters (ie, the available parameters predict weaning failure poorly),3 36 37 it appears most prudent to conduct daily assessments of the patient’s ability to breathe spontaneously.8 9 11 32 Clinicians should have a low threshold to perform such a trial. Yet, in a recent international utilization review38 of the actual weaning practices of 412 medical and surgical ICUs in 1,638 patients receiving MV, only 20% of patients were weaned using some form of SBT, and in the United States, SBTs were incorporated into weaning in < 10% of all patients studied. Patients chosen for SBTs should be in hemodynamically stable condition, and their condition should be improving with regard to the underlying cause of respiratory failure. SBTs can be performed safely by nonphysician HCPs using a T-piece, continuous positive airway pressure without pressure support, or with pressure support up to 7 cm H2O, and for durations of 30 min to 2 h.6 8 9 11 32 34 39 40 The monitored assessment of spontaneous breathing should be conducted at least once daily (with the head of the bed elevated and after notifying the patient of the start of the SBT) and should be integrated with other major events in the patient’s daily care, including the cessation or temporary reduction in delivery of sedation and analgesia medications.41 There are emerging data about the utility of noninvasive positive-pressure ventilation to facilitate weaning and to avoid reintubation,42 43 44 45 as well as ongoing multicenter trials that are studying protocols using this modality of respiratory support for weaning patients from MV.

Recommendation 3: Based on evidence from randomized trials, we recommend at least once daily SBTs to identify patients who are ready for liberation from the ventilator.

Recommendations for Patients Who Are "Not-Yet-Ready" for Liberation
When a patient does not demonstrate readiness for liberation from the mechanical ventilator, but is improving as indicated by lessening support requirements, the clinician is faced with a decision about how to wean MV support. In randomized trials, both Esteban et al8 and Brochard et al32 employed a screening process whereby patients were enrolled into the trials only if they failed to demonstrate readiness via an SBT. In these studies, either once-daily SBTs or pressure support ventilation were both superior to intermittent mandatory ventilation alone. Reported differences in the superiority of SBTs vs pressure support ventilation have been attributed to variations in the management protocols. The value of differing modes depends on thresholds for initiating, progressing through, and terminating weaning. Unfortunately, these thresholds involve more than objective data and appear to be related to physician judgment.1 Therefore, based on evidence from these investigations, we can offer the following recommendations.

Recommendation 4: When patients fail an SBT, we recommend the following assessments and interventions, based on varying levels of evidence:

  1. All remediable factors should be addressed to enhance the prospects of successful liberation from MV (eg, electrolyte derangements, bronchospasm, malnutrition, patient positioning, or excess secretions).
  2. The patient should be placed in an upright position46 on a comfortable, safe, and well-monitored mode of MV (such as pressure support ventilation).
  3. An SBT should be performed at least once daily. Few data support multiple manipulations of ventilator settings each day in an effort to wean or "train" the patient. For clinicians who prefer stepwise reductions in MV, both multiple daily SBTs and weaning pressure support ventilation appear to be superior to intermittent mandatory ventilation.8 32
  4. In the face of repeated failures at daily SBTs, clinicians should consider longer-term options, including both tracheotomy and a long-term acute-care or stepdown ventilator facility.47

Extubation Decisions
The clinical trials6 8 9 11 32 discussed above each outlined a rigid extubation protocol or, alternatively, an approach that incorporated the clinician’s judgment and preferences for the timing of extubation. Despite the care and rigor with which a team of HCPs evaluates their patients’ abilities to be liberated from MV, some patients will require reintubation,5 48 which carries an estimated 8-fold higher odds ratio for nosocomial pneumonia49 and a 6-fold to 12-fold increased mortality risk.4 6 39 50 Reported reintubation rates range from 4 to 20% for different ICU populations4 5 6 8 9 32 34 51 and may be as high as 33% in patients with mental status changes and neurologic impairment.48 The optimal rate of reintubation is not known but likely rests between 5% and 15% in non-neurologically impaired patients.

One important cause of reintubation is self-extubation or accidental extubation of patients who are inadequately sedated and/or restrained. However, self-extubation also can occur in patients who are ready to be liberated from the ventilator. For instance, approximately 50% of patients who self-extubate do not require reintubation.50 52 53 54 55 This fact should further motivate physicians to adopt proactive protocols directed toward earlier extubation. In fact, two investigations have shown an associated reduction in reintubation rates by incorporating a protocol driven by nonphysician HCPs.9 56

Recommendation 5: Based on the sum of evidence from randomized trials and observational studies, we recommend that when patients have passed an SBT, clinicians seriously consider prompt extubation.

Sedation and Analgesia
When other key features in the management of patients receiving MV, such as sedation and analgesia, are protocolized and managed by nonphysician HCPs, further reductions in the time spent receiving MV can be realized. Standardizing the delivery of sedatives and analgesics is the most recent development in the area of protocolization and weaning from MV. One RCT, using a nursing-implemented protocol to manage the delivery of sedation, showed a reduction in the duration of MV by 2 days (p = 0.008), decreased length of stay in the ICU by 2 days (p < 0.0001), and a lower tracheostomy rate among the treatment group (6% vs 13%; p = 0.04).41 In another recently published RCT57 among 128 patients receiving MV in an ICU, those in whom sedation was maintained at a lighter level (via daily interruption of their sedative infusion) spent 2 days less receiving MV (p = 0.004) and 3 days less in the ICU (p = 0.02) than did patients in whom infusions were not interrupted. In addition, the pharmacoeconomic impact of guidelines for analgesia, sedation, and neuromuscular blockade appear to be favorable and have received more attention in the medical literature recently.58 In summary, these studies have demonstrated the important interactions between the delivery of psychoactive medications and the expeditious weaning from MV. However, considering the nearly universal use of these agents in patients receiving MV and the relative paucity of controlled investigations in this area,59 further study is required before detailed and specific methods of protocolization can be recommended. For example, studies to date have monitored only the arousal component of consciousness and have tracked relatively few adverse events, none of which included patients’ distress during awakening, recollections of discomfort after their stay in the ICU, delirium, or persistent neuropsychological outcomes. Emerging work in the area of the content of consciousness (eg, delirium) is revealing important interactions between the development of delirium and outcomes including the duration of the hospital stay, as well as long-term neuropsychological outcomes.60 61 62

Recommendation 6: Based on evidence from randomized trials for the delivery of psychoactive medications, we recommend the consideration of protocols that include daily cessation and targeted sedation goals to reduce the duration of MV and of the length of stay in the ICU.

Implementation of Protocols
Both the level of institutional commitment to improving clinical outcomes and the health-care team’s leadership, persistence, and consistency in the implementation of protocols will determine the ultimate success of any management protocol. Protocolized care has been advocated in many facets of medicine, but relinquishing control of the patient’s management often creates resentment and frustration on the part of physicians. Even when research clearly supports a change in approach, it is very difficult to get physicians to alter their practice and management styles.63 Certain physicians may have a low "readiness to change," and these professionals may require either motivational interventions or consultation with respected opinion leaders.64 65 Negative reactions to protocols may be reasonable under some circumstances, since protocols have the potential to do harm. Important considerations that may facilitate behavioral changes include interactive education, timely and specific feedback, participation by physicians in the effort to change, administrative interventions, and even financial incentives and penalties.63 Through a staged implementation process, using periodic reinforcement of all participants in ventilator management and the close monitoring of compliance with the protocol, large-scale implementation within major medical centers is possible.34 Protocol implementation (and acceptance) is potentially less complicated in smaller, self-contained units with fewer staff and more direct communication channels. Tips for the implementation of weaning protocols and for avoiding barriers to success, which were derived from the study of > 15,000 patient-days of MV over nearly 2 years of implementation,65 are presented in Table 6 . The effective implementation of protocols requires adequate staffing, and it has been shown that if staffing is reduced below certain thresholds, clinical outcomes may be jeopardized.66 67 Indeed, in the specific context of liberation from MV, reductions in nurse-to-patient ratios have been associated with a prolonged duration of MV.68


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  		Table 6. Tips for Implementation of Protocols to Maximize the Likelihood of Success in Achieving Both a Change of Behavior on the Part of HCPs and Long-term Protocol Implementation

 
It is imperative that protocols not be used to replace clinical judgment, but rather to complement it. Protocols are meant to guide patient care and may serve as the general default management, unless they are based on patient response or if any of the HCPs (ie, physicians, nurses, or RCPs) can justify a departure from the protocol. Likewise, protocols should not be viewed as rigid rules, but rather as dynamic tools in evolution that can be improved on to address local problems and to accommodate new data. More studies regarding the impact of protocol-based weaning are needed to better delineate optimal approaches in specific patient populations (eg, neurosurgical,69 70 trauma,12 71 or COPD patients42 ), in specific organizational structures (eg, open vs closed units or teaching vs community hospitals72 ), and using computer-assisted decision making.73 74

Recommendation 7: We recommend the consideration of the following strategies for weaning protocols: development using an evidence-based approach by a multidisciplinary team; and implementation using effective behavior-changing strategies such as interactive education, opinion leaders, reminders, audit, and feedback.

In summary, this evidence-based review suggests that protocols driven by nonphysician HCPs to manage the weaning and liberation of patients from MV can reduce the time that patients spend receiving MV. We have developed seven key recommendations to synthesize this information for those attempting to design a weaning protocol. We also have discussed key general issues to aid in protocol implementation. Acknowledging the important nuances in protocols that should be dictated by specific patient populations and institutional preferences, the following two steps in any successful weaning attempt derived from recent RCTs9 11 12 41 57 bear repeating: step A should involve minimizing or temporarily discontinuing sedation and analgesia enough to observe patient awakening; and step B should involve an assessment of the patient’s ability to spontaneously breathe.

The data included in this systematic review and a more comprehensive discussion of the original articles are included in an Evidence Report of the Agency for Healthcare Research and Quality.75


   Footnotes
 
Abbreviations: AHCPR = Agency for Health Care Policy and Research; CI = confidence interval; HCP = health-care professional; MV = mechanical ventilation; RCP = respiratory-care practitioner; RCT = randomized controlled trial; RR = relative risk; SBT = spontaneous breathing trial

This article is based on work performed by the McMaster University Evidence-based Practice Center, under contract to the Agency for Healthcare Research and Quality (Contract No. 290-97-0017), Rockville, MD.


   References
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 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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