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(Chest. 2006;130:1664-1671.)
© 2006 American College of Chest Physicians

Risk Factors for Extubation Failure in Patients Following a Successful Spontaneous Breathing Trial*

Fernando Frutos-Vivar, MD; Niall D. Ferguson, MD, MSc; Andrés Esteban, MD, PhD; Scott K. Epstein, MD, FCCP; Yaseen Arabi, MD, FCCP; Carlos Apezteguía, MD; Marco González, MD; Nicholas S. Hill, MD, FCCP; Stefano Nava, MD; Gabriel D’Empaire, MD and Antonio Anzueto, MD

* From the Hospital Universitario de Getafe (Drs. Frutos-Vivar and Esteban), Madrid, Spain; the Department of Medicine (Dr. Ferguson), Division of Respirology, and the Interdepartmental Division of Critical Care Medicine, University Health Network, University of Toronto, Toronto, ON, Canada; the Department of Medicine (Dr. Epstein), Caritas-St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA; King Abdulaziz Medical City (Dr. Arabi), Riyadh, Saudi Arabia; Hospital Profesor Posadas (Dr. Apezteguía), Buenos Aires, Argentina; Hospital General de Medellín (Dr. González), Medellín, Colombia; Pulmonary and Critical Care Division (Dr. Hill), Department of Medicine, New England Medical Center, Tufts University School of Medicine, Boston, MA; Respiratory Intensive Care Unit (Dr. Nava), Fondazione S. Maugeri, Istituto Scientifico di Pavia, Pavia, Italy; Hospital de Clínicas (Dr. D’Empaire), Caracas, Venezuela; and South Texas Veterans Health Care System (Dr. Anzueto), San Antonio, TX.

Correspondence to: Fernando Frutos-Vivar, MD, Intensive Care Unit, Hospital Universitario de Getafe, Carretera de Toledo km 12,500, 28905 Getafe, Madrid, Spain; e-mail: ffrutos{at}ucigetafe.com

Abstract

Background: To assess the factors associated with reintubation in patients who had successfully passed a spontaneous breathing trial.

Methods: We used logistic regression and recursive partitioning analyses of prospectively collected clinical data from adults admitted to ICUs of 37 hospitals in eight countries, who had undergone invasive mechanical ventilation for > 48 h and were deemed ready for extubation.

Results: Extubation failure occurred in 121 of the 900 patients (13.4%). The logistic regression analysis identified the following associations with reintubation: rapid shallow breathing index (RSBI) [odds ratio (OR), 1.009 per unit; 95% confidence interval (CI), 1.003 to 1.015]; positive fluid balance (OR, 1.70; 95% CI, 1.15 to 2.53); and pneumonia as the reason for initiating mechanical ventilation (OR, 1.77; 95% CI, 1.10 to 2.84). The recursive partitioning analysis allowed the separation of patients into different risk groups for extubation failure: (1) RSBI of > 57 breaths/L/min and positive fluid balance (OR, 3.0; 95% CI, 1.8 to 4.8); (2) RSBI of < 57 breaths/L/min and pneumonia as reason for mechanical ventilation (OR, 2.0; 95% CI, 1.1 to 3.6); (3) RSBI of > 57 breaths/L/min and negative fluid balance (OR, 1.4; 95% CI, 0.8 to 2.5); and (4) RSBI of < 57 breaths/L/min (OR, 1 [reference value]).

Conclusions: Among routinely measured clinical variables, RSBI, positive fluid balance 24 h prior to extubation, and pneumonia at the initiation of ventilation were the best predictors of extubation failure. However, the combined predictive ability of these variables was weak.

Key Words: artificial respiration • extubation • predictive index • reintubation • ventilator weaning

Both delayed and premature discontinuation of mechanical ventilation have been associated with increased mortality.1234567 Multiple randomized trials28910111213 have demonstrated that the duration of ventilation can be reduced safely by a strategy employing daily assessments for readiness to wean, followed by prompt extubation after a successful spontaneous breathing trial. However, this approach to weaning still results in an extubation failure rate (ie, the need for reintubation within 48 to 72 h) of 10 to 20%.910111213 Thus, there is a need to determine what factors may be associated with this failure rate.

Attention has now moved to refining the second stage in the liberation process, namely, the decision to extubate after having passed a spontaneous breathing trial.3 Studies from the past few years7141516 have focused on the association of extubation outcomes with variables that assess the ability to protect the airway. These studies have reported that the risk of extubation failure is increased with ineffective cough, a propensity for aspiration, and abundant secretions, while a decreased level of consciousness was not consistently identified as a risk factor for failure. However, the results of these studies may not be widely generalizable, as they were performed at single centers or in specific populations,7141516 with relatively small sample sizes. In addition, many of their specific predictor variables, such as cough, peak flow, and secretion volume, are difficult to measure in daily clinical practice.

The objective of our multicenter international study was to assess prospectively the variables associated with reintubation in a heterogeneous group of mechanically ventilated patients who were extubated after having successfully completed a spontaneous breathing trial.

Materials and Methods

Patients
Between November 1999 and May 2002, consecutive patients > 18 years of age, who had undergone invasive mechanical ventilation for > 48 h and had been extubated following a successful spontaneous breathing trial, were enrolled from the ICUs of 37 hospitals in eight countries. The research ethics board at each center approved the study and informed consent was obtained at the time of enrollment. Patients with a tracheostomy were excluded. Each of the study ICUs used the same general methodology for weaning patients from mechanical ventilation. Patients were assessed daily for the presence of the following readiness-to-wean criteria: (1) improvement in the underlying condition that led to acute respiratory failure; (2) alert and able to communicate; (3) core temperature not > 38°C; (4) no therapy with vasoactive drugs (excluding dopamine, < 5 µg/kg/min); and (5) adequate gas exchange, as indicated by a PO2 of at least 60 mm Hg with an inspired fraction of oxygen of ≤ 0.40 and a positive end-expiratory pressure not > 5 cm H2O. Patients meeting these criteria were then weaned using one of the following techniques: (1) daily trial of spontaneous breathing for up to 120 min using a T-tube, continuous positive airway pressure, flow-by, or pressure support of < 8 cm H2O; (2) multiple daily trials of spontaneous breathing, as cited above; or (3) gradual reductions of pressure support until a level of ≤ 7 cm H2O was reached. All patients ultimately passed a spontaneous breathing trial and were extubated.

Data Collection
We recorded demographic data and the severity of illness at the time of ICU admission. The reason for the initiation of mechanical ventilation was recorded using the same classification system and definitions as those used in another large international observational study17; specifically, pneumonia was defined as the presence of new or worsening radiographic alveolar infiltrates along with fever or hypothermia, and leukocytosis or leukopenia. The presence of cardiovascular events (shock or acute coronary syndrome) over the course of mechanical ventilation, the duration of mechanical ventilation, and the method of weaning were also documented. We prospectively collected the following data during the 24 h before extubation: tracheal secretions volume (none, minimal, or abundant) and consistency (normal or purulent); subjective efficacy of cough (poor, moderate, or excellent); WBC count > 12,000 per µL; temperature > 38°C; administration of sedatives; and fluid balance (calculated as fluid input minus output over the 24-h period). Tracheobronchial aspirates were sent for semi-quantitative culture. We considered culture findings to be positive if > 105 cfu/mL potentially pathogenic organisms were isolated. After successful completion of a spontaneous breathing trial and immediately prior to extubation, investigators documented the following: (1) patients’ ability to cooperate (poor, moderate, and excellent); (2) a 1-min observation of respiratory frequency and tidal volume measured through a spirometer or from the ventilator display (to calculate the rapid shallow breathing index [RSBI]18); (3) maximal inspiratory pressure; and (4) oxygen saturation. If available, the arterial blood gas levels were recorded.

After extubation, patients were followed up for the presence of postextubation respiratory distress. Patients in whom acute respiratory failure developed were randomized to receive either noninvasive positive-pressure ventilation or usual care.19 In both groups, patients were reintubated if they met at least one of the following criteria: lack of improvement and/or worsening in arterial pH or PCO2; decreased mental status; decrease in the oxygen saturation to < 85%, despite the use of a high fraction of inspired oxygen; lack of improvement in signs of respiratory muscle fatigue; hypotension, with a systolic BP < 90 mm Hg for > 30 min despite adequate volume loading, the use of vasopressors, or both; and copious secretions that the patient could not adequately clear.

Statistical Analysis
Results are expressed as the mean and SD, median and interquartile range, and proportions, as appropriate. We used the Student t test or the Mann-Whitney U test to compare continuous variables, and the {chi}2 test or the Fisher exact test to compare proportions, as appropriate. Two-tailed p values of < 0.05 were used to indicate statistical significance.

To estimate the simultaneous effects of multiple variables on reintubation, a multivariate analysis was performed using a conditional logistic regression model and a backward stepwise selection method to correct for collinearity. We used a significance threshold of p < 0.10 for entering tested variables into the model. A recursive portioning analysis (Answer Tree; SPSS Inc; Chicago, IL) was subsequently performed using the significant variables from the multivariable logistic regression, in order to derive clinically relevant subgroups of patients at different risks for reintubation. This method identified threshold values for each variable, which provided the best separation of the study population according to reintubation status. The resultant classification tree grouped patients into distinct groups using combinations of variables that jointly influenced the likelihood of reintubation. Odds ratios (ORs) and 95% confidence intervals (CIs) were then calculated for each of these distinct groups using a dummy variable entered into a logistic regression equation. We also calculated likelihood ratios for each risk category using standard methods.20

Results

A total of 980 patients fulfilled the study entry criteria and were electively extubated. We excluded from our analysis two patients who required immediate reintubation because of upper airway obstruction (ie, glottic edema), and 78 patients in whom the data for the predictor variables had not been recorded. Overall, extubation failure occurred in 121 of the 900 patients included in this analysis (13.4%). Table 1 shows the baseline characteristics of the study cohort according to reintubation status. The reasons for reintubation were lack of improvement in work of breathing (55 of 121 patients; 45%), hypoxemia (27 of 121 patients; 22%), respiratory acidosis (13 of 121 patients; 11%), retained secretions (12 of 121 patients; 10%), decreased level of consciousness (7 of 121 patients; 6%), and hypotension (7 of 121 patients; 6%). Patients who required reintubation were older and more likely to have had pneumonia as their reason for receiving mechanical ventilation. In addition, by univariate analysis these patients had higher RSBI values (Fig 1 ) and were more likely to have a positive fluid balance in the 24 h prior to extubation (Fig 2 ).


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  		Table 1. Characteristics of the Study Cohort*

 

Figure 1
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  		Figure 1. Reintubation rate by RSBI group. Patients were divided into categories according to RSBI values immediately prior to extubation using arbitrary steps of 25 breaths/min/L. Columns depict the reintubation rate for each category. The numbers on top of the columns are the numeric reintubation rates, while the numbers placed inside the columns indicate the number of patients in each category.

 

Figure 2
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  		Figure 2. Reintubation rate by fluid balance category. Patients were divided into categories according to fluid balance in the 24 h prior to extubation using arbitrary steps of 1 L. Columns depict the reintubation rate for each category. The numbers on top of the columns are the numeric reintubation rates, while the numbers placed inside the columns indicate the number of patients in each category.

 
The logistic regression analysis identified the following variables as being associated with reintubation: RSBI (OR, 1.009 per unit; 95% CI, 1.003 to 1.015); positive fluid balance (OR, 1.70; 95% CI, 1.15 to 2.53); and pneumonia as the reason for initiating mechanical ventilation (OR, 1.77; 95% CI, 1.10 to 2.84). The recursive partitioning analysis identified thresholds for these variables that allowed the greatest separation of patients into different risk groups for extubation failure (Fig 3 ). The probability of reintubation in each distinct risk group defined by the recursive partitioning analysis and the likelihood ratios for extubation failure in the defined groups are shown in Table 2 .


Figure 3
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  		Figure 3. Recursive partitioning tree. Results of the recursive partitioning analysis are illustrated, whereby each patient is ultimately assigned to one of four distinct risk groups for reintubation. Patients are first divided according to their RSBI, and subsequently either by their fluid balance or the presence of pneumonia as their reason for the initiation of ventilation. The proportions (percentage) of patients reintubated in each group are displayed.

 

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  		Table 2. Risk Subgroups for Reintubation From the Recursive Partitioning Analysis*

 
Discussion

In a heterogeneous cohort of mechanically ventilated patients who were extubated after a successful spontaneous breathing trial, we found that reintubation within 72 h was associated with a RSBI value of > 57 breaths/min/L, a positive fluid balance within 24 h prior to extubation, and pneumonia as the cause for initiating mechanical ventilation. In the original description of the RSBI, Yang and Tobin18 identified a threshold value of 105 breaths/min/L as a predictor of weaning failure. Weaning failure was defined as either the failure of a spontaneous breathing trial (in which case patients were not extubated) or as the failure of extubation after a successful spontaneous breathing trial. Almost 15 years later, we now appreciate that predicting the success or failure of a spontaneous breathing trial is less important. Spontaneous breathing trials are safe, well-tolerated, and easy to perform. What now seems more important is to predict the success of extubation following the successful completion of a trial of spontaneous breathing. Thus, several studies have assessed the RSBI as a predictor of outcome after extubation. Bien et al21 reported that reintubated patients had a significantly higher median RSBI (69 vs 45 breaths/min/mL, respectively; p < 0.05). Other studies1416 have shown similar differences between successful and failed extubations, but these did not reach statistical significance. Smina et al,15 however, reported a significant difference in RSBI between reintubated patients and those who had not been reintubated (median, 88 vs 60 breaths/min/L, respectively; p = 0.03). Furthermore, these investigators found that an RSBI of > 100 breaths/min/L was an independent predictor of extubation failure. Similar results were recently reported by Upadya et al.22 In our study, the RSBI was an independent predictor of extubation failure, and a value > 57 breaths/min/L increased the risk of reintubation from 11 to 18%.

Congestive heart failure has been suggested as an important reason for weaning failure. Lemaire et al23 reported a cohort of 15 patients with severe COPD and cardiovascular disease in whom there was an increase in pulmonary artery occlusion pressure during weaning that resulted in extubation failure. After treatment with diuretics, 9 of the 15 patients were successfully weaned from mechanical ventilation.23 Similarly, Cabello et al24 reported in 2004 that congestive heart failure was the cause of weaning failure in 7 of 12 patients (58%) who failed a spontaneous breathing trial. Epstein and Ciubotaru,25 in a study of 74 patients who required reintubation within 72 h of extubation, reported that congestive heart failure was the reason for extubation failure in 23% of the patients. In our study, patients with a positive fluid balance in the 24 h before extubation had a higher likelihood of being reintubated. A limitation of our study is that we did not collect any hemodynamic or echocardiographic measurements to be able to correlate positive fluid balance with ventricular dysfunction. It is possible that patients who failed extubation due to a positive fluid balance had poor cardiovascular reserves and were not able to handle the volume overload. It is also possible, however, that fluid balance is acting as a general marker of recovery from acute illness in our study population. Patients who have an ongoing inability to regulate the integrity of their vascular space and achieve a negative fluid balance may also be less likely to be successfully extubated. Similar results have been reported by Upadya et al.22 In a prospective study including 87 patients these authors22 observed that a positive cumulative fluid balance from hospital admission to weaning was associated with weaning failure. Although in this study the administration of diuretics was not associated with improved weaning outcomes, we agree with these authors that further prospective studies will be necessary to assess the value of hemodynamic monitoring and the role of diuretic therapy in the prevention of reintubation. In relation to this issue, the recently published study26 on fluid management in patients with acute lung injury could support the observation that fluid restriction is associated with a shorter time period for needing ventilation.

Pneumonia as the reason to initiate mechanical ventilation was the third variable related to reintubation in our study. The only other difference that we identified in these patients was that they were more likely to have tracheal aspirates positive for pathogens prior to extubation (30.5% of patients with pneumonia had > 105 microorganisms that were potentially pathogens in their tracheal aspirates prior to extubation vs 18% of patients without pneumonia; p < 0.001). Other variables such as fever, leukocytosis or purulent secretions were similar between patients with and without pneumonia at the time of extubation. These findings suggest that patients may not have fully cleared the microbial load from their pneumonia, and therefore continued to require ventilatory support.

Extubation failure remains a difficult outcome to predict. We were unable to clearly define a subgroup of patients who were at very high risk of reintubation using predictor variables that are measured in routine practice. Studies141516 have highlighted the importance of cough strength and the amount of bronchial secretions as factors related to reintubation. On univariate analysis, we identified that tracheal aspirate cultures with positive findings were more common in patients who required reintubation, but this variable did not retain statistical significance in the multivariate analysis. Cough strength, amount of secretions, level of consciousness, or patient cooperation was not associated with extubation outcome in our study. There are several reasons that may explain the differences between our findings and those of the previous studies. In our cohort, the decision to extubate was protocolized; however, the physician in charge of the patient made the final decision, and it is possible that some physicians delayed extubation until patients showed an improvement in some of these variables. Furthermore, in our study the frequency of weak cough and/or abundant amount of secretions was lower than previously observed. We also observed differences in the reintubation rate of patients with the worst-case clinical scenario, as described by Salam et al.16 These investigators found that all patients who were unable to cooperate, and had abundant secretions and a weak cough required reintubation. In our study, these three conditions were all present in 5% of the population, but their reintubation rate was only 17%.

In summary, in a large cohort of mechanically ventilated patients passing a spontaneous breathing test and judged clinically appropriate to extubate, we were able to demonstrate that the RSBI, a positive fluid balance 24 h prior to extubation, and pneumonia as the cause for initiating mechanical ventilation were the best predictors of extubation failure. However, the combined predictive ability of these variables was weak, as evidenced by likelihood ratios that result in only modest changes from the pretest probability of extubation failure. Future studies are needed to search for other variables that are predictive of extubation failure while still being widely applicable in routine care.

Appendix

Participating Study Investigators
Argentina
S. Bauque and S. Giannasi (Hospital Italiano de Buenos Aires); L. Bettini and A.R. Diez (Hospital Provincial del Centenario de Rosario); H.S. Canales (Hospital Interzonal General de Agudos General San Martin de la Plata de Mar del Plata); M.F. Costa and H. Solar (Hospital Profesor Posadas de Haedo); P.M. Desmery and A. Gómez (Sanatorio Mitre de Buenos Aires); P. Gómez and O. Yunk (Hospital Español de Buenos Aires); M. Grill and W. Vázquez (Hospital Español de Mendoza); E. Turchetto (Hospital Privado de la Comunidad de Mar del Plata); and R. Valentín (Centro de Estudios Médicos e Investigaciones Clínicas de Buenos Aires).

Brazil
M.A. Soares and I.M. de Oliveira Rezende (Hospital Universitario São José, Belo Horizonte).

Colombia
B. Gil (Clínica Medellín de Medellín); M. Granados (Fundación Valle de Lily de Cali); A. Guerra (Hospital General de Medellín and Clínica Soma de Medellín); and F. Molina (Clínica Universitaria Bolivariana de Medellín).

Saudi Arabia
S. Haddad (King Fahad National Guard Hospital of Riyadh).

Spain
A. Abella and M. Prieto (Hospital Universitario de Getafe, Madrid); J.M. Allegue and S. Rodríguez Fernández (Hospital Santa Maria del Rosell, Cartagena); S. Alonso and C. Boqué (Hospital Universitario Joan XXIII, Tarragona); A. Belenguer and T. Mut (Hospital General de Castellón); S. Benito and A. Claramunt (Hospital de Santa Creu i Sant Pau, Barcelona); J. Blanco (Hospital del Río Hortega, Valladolid); J.L. Buendía and J.A. Gómez Rubí (Hospital Virgen de la Arrixaca, El Palmar); R. Fernández Fernández and M.M. Fernández Fernández (Complejo Hospitalari de Parc Taulí, Sabadell); J. Gener and R. Tomás (Hospital Germans Trias i Pujol, Badalona); S. Macias and F. Martínez Soba (Hospital General de Segovia); and F. Esteban and I. Vallverdú (Hospital Universitari de Reus, Tarragona).

United States
J. Houtchens and T. Liesching (Rhode Island Hospital, Brown University Medical School, Providence, RI); A. Pelaez and D. Vines (University of Texas Health Science Center, San Antonio); and N. Singh (New England Medical Center, Tufts University School of Medicine, Boston).

Venezuela
M. Capdevielle (Hospital Universitario de Caracas); J.M. España (Hospital Universitario de Caracas); A. Medina (Hospital Militar); F. Pérez (Hospital de Clínicas de Caracas); and R.A. Zerpa (Hospital Militar).

Footnotes

Abbreviations: CI = confidence interval; OR = odds ratio; RSBI = rapid shallow breathing index

This research was supported by grant 00/315 from the Fondo de Investigación Sanitaria; by grants Red Gira G03/063 and Red Respira C03/11 from the Instituto de Salud Carlos III, Spain; and by a Canadian Institutes of Health Research-Canadian Lung Association Post-Doctoral Fellowship (to Dr. Ferguson).

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Received for publication July 8, 2006. Accepted for publication September 2, 2006.

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Risk Factors for Extubation Success in Patients Following Failure of a Spontaneous Breathing Trial
Chest, May 1, 2007; 131(5): 1615 - 1615.
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