A Comparison of Four Methods of Weaning Patients from Mechanical Ventilation
Andrés Esteban, M.D., Ph.D., Fernando Frutos, M.D., Martin J. Tobin, M.D., Inmaculada Alía, M.D., José F. Solsona, M.D., Valverdú Valverdu, M.D., Rafael Fernández, M.D., Miguel A. de la Cal, M.D., Salvador Benito, M.D., Ph.D., Roser Tomás, M.D., Demetrio Carriedo, M.D., Santiago Macías, M.D., Jesús Blanco, M.D., for The Spanish Lung Failure Collaborative Group
Background Weaning patients from mechanical ventilation is animportant problem in intensive care units. Weaning is usuallyconducted in an empirical manner, and a standardized approachhas not been developed.
Methods We carried out a prospective, randomized, multicenterstudy involving 546 patients who had received mechanical ventilationfor a mean (±SD) of 7.5±6.1 days and who wereconsidered by their physicians to be ready for weaning. Onehundred thirty patients had respiratory distress during a two-hourtrial of spontaneous breathing. These patients were randomlyassigned to undergo one of four weaning techniques: intermittentmandatory ventilation, in which the ventilator rate was initiallyset at a mean (±SD) of 10.0±2.2 breaths per minuteand then decreased, if possible, at least twice a day, usuallyby 2 to 4 breaths per minute (29 patients); pressure-supportventilation, in which pressure support was initially set at18.0±6.1 cm of water and then reduced, if possible, by2 to 4 cm of water at least twice a day (37 patients); intermittenttrials of spontaneous breathing, conducted two or more timesa day if possible (33 patients); or a once-daily trial of spontaneousbreathing (31 patients). Standardized protocols were followedfor each technique.
Results The median duration of weaning was 5 days for intermittentmandatory ventilation (first quartile, 3 days; third quartile,11 days), 4 days for pressure-support ventilation (2 and 12days, respectively), 3 days for intermittent (multiple) trialsof spontaneous breathing (2 and 6 days, respectively), and 3days for a once-daily trial of spontaneous breathing (1 and6 days, respectively). After adjustment for other covariates,the rate of successful weaning was higher with a once-dailytrial of spontaneous breathing than with intermittent mandatoryventilation (rate ratio, 2.83; 95 percent confidence interval,1.36 to 5.89; P<0.006) or pressure-support ventilation (rateratio, 2.05; 95 percent confidence interval, 1.04 to 4.04; P<0.04).There was no significant difference in the rate of success betweenonce-daily trials and multiple trials of spontaneous breathing.
Conclusions A once-daily trial of spontaneous breathing ledto extubation about three times more quickly than intermittentmandatory ventilation and about twice as quickly as pressure-supportventilation. multiple daily trials of spontaneous breathingwere equally successful.
Although often lifesaving, mechanical ventilation causes numerouslife-threatening complications,1 making it important to discontinueventilator support at the earliest possible time. More than40 percent of the time that a patient receives mechanical ventilationis spent trying to wean the patient from the ventilator.2 Consideringthe proportion of staff time devoted to weaning, it is surprisingthat the process continues to be managed empirically and thata standardized approach has not been developed.
Weaning techniques differ considerably from one another.3 Traditionally,intermittent trials of spontaneous breathing, conducted oneor more times a day, have been used. Intermittent mandatoryventilation was introduced amid claims that it was superiorto the traditional weaning approach. It allows the patient tobreathe spontaneously between ventilator-delivered breaths4;thus, weaning can be considered to begin with the institutionof mechanical ventilation. In the 1980s, pressure-support ventilationbecame available5; it provides a titratable pressure boost toevery inspiratory effort, and weaning is accomplished by graduallydecreasing the level of the pressure boost.
Efficacy studies of weaning techniques can be faulted for havinga retrospective design, inappropriate study populations, andpoorly standardized protocols; in addition, most were conductedbefore the use of pressure-support ventilation became widespread.6-8Accordingly, we performed a prospective, randomized study involvingpatients who were deemed ready to discontinue mechanical ventilation.In a subgroup of patients who were difficult to wean we comparedthe length of time required for weaning with the use of fourtechniques: intermittent mandatory ventilation, pressure-supportventilation, intermittent trials of spontaneous breathing conductedseveral times a day, and a once-daily trial of spontaneous breathing.
Methods
Patients
The study was conducted between October 1992 and October 1993in the medical–surgical intensive care units of 14 teachinghospitals in Spain. The study population consisted of 546 patients(378 men and 168 women), with a mean (±SD) age of 58.2±18.4years. All received mechanical ventilation for more than 24hours because of acute respiratory failure. The following underlyingconditions were present: chronic obstructive pulmonary diseasewith acute respiratory failure in 128 patients, acute lung injuryin 319, neurologic or neuromuscular disorders in 85, and miscellaneouscauses in 14. The acute lung injury was a result of surgeryin 74 patients, infection in 73, heart failure in 69, multipletrauma in 51, adult respiratory distress syndrome in 23, andother pulmonary causes in 29. On admission to the intensivecare unit, the patients had a mean score of 18.7±7.0on the Acute Physiology and Chronic Health Evaluation (APACHEII) scale.9 Until the first attempt was made to discontinueventilator support, all patients received assist–controlventilation. The patients received mechanical ventilation fora mean of 7.5±6.1 days before weaning was started. Nohospital contributed more than 10 percent of the study population.
To be enrolled in the study the patients had to have an improvementin or resolution of the underlying cause of acute respiratoryfailure; adequate gas exchange, as indicated by a ratio of thepartial pressure of arterial oxygen (PaO2) to the fraction ofinspired oxygen (FiO2) above 200 with a positive end-expiratorypressure of <5 cm of water; a core temperature below 38°C;a hemoglobin level above 10 g per deciliter; and no furtherneed for vasoactive and sedative agents. In addition, the attendingphysician had to agree that the patient was in stable conditionand ready to be weaned from the ventilator. Patients with atracheostomy were excluded. The study was approved by the ethicscommittees of the hospitals, and the patients provided informedconsent.
Protocol
After patients were enrolled in the study, assist–controlventilation was stopped and the patients breathed spontaneouslyfor three minutes through a T-tube circuit, with the FiO2 setat the same level (0.38±0.05) as that used during mechanicalventilation. Tidal volume and respiratory frequency were measuredwith a spirometer during this period. Maximal inspiratory pressurewas measured three times in succession, and the most negativevalue was selected. Patients who met at least two of the followingcriteria underwent a trial of spontaneous breathing lastingup to two hours: maximal inspiratory pressure below -20 cm ofwater, tidal volume above 5 ml per kilogram of body weight,and a respiratory frequency of less than 35 breaths per minute.Weaning was considered to have begun with the onset of thistrial. During this trial, patients received humidified oxygen-enrichedgas through a T-tube circuit. The primary physician terminatedthe trial if a patient had any of the following signs of distress:a respiratory frequency of more than 35 breaths per minute,arterial oxygen saturation below 90 percent, heart rate above140 beats per minute or a sustained increase or decrease inthe heart rate of more than 20 percent, systolic blood pressureabove 180 mm Hg or below 90 mm Hg, agitation, diaphoresis, oranxiety. Patients who had none of these features at the endof the trial were extubated. After extubation, the patientsreceived supplemental oxygen by face mask. If a patient hadsigns of poor tolerance at any time during the trial, assist–controlventilation was reinstituted. For the purpose of the study,these patients were designated as being difficult to wean frommechanical ventilation.
Even if there were no signs of distress by the end of this trial,extubation could be postponed for a maximum of 24 hours if theprimary physician thought that a patient might not be able toclear secretions or protect the airway against aspiration. Patientscontinued to breathe spontaneously through the T-tube circuit.If they met criteria for poor tolerance, mechanical ventilationwas reinstituted. These patients were not included in the weaning-protocolgroup.
Patients who were designated as being difficult to wean frommechanical ventilation were stratified according to center andrandomly assigned with the use of a random-number table10 tobe weaned in one of four ways: intermittent mandatory ventilation,pressure-support ventilation, intermittent trials of spontaneousbreathing, and a once-daily trial of spontaneous breathing.The patients were assigned to the groups in a blinded fashionwith the use of opaque, sealed, numbered envelopes, which wereopened only when a patient did not successfully complete thetwo-hour trial of spontaneous breathing. All adjustments foreach weaning technique were made by the primary physician.
Intermittent Mandatory Ventilation
In the group that received intermittent mandatory ventilation,the ventilator rate was initially set at half the frequencyused during assist–control ventilation; this initial ratewas 10.0±2.2 breaths per minute, and mechanical breathswere synchronized with inspiratory effort. We attempted to decreasethe ventilator rate, usually by two to four breaths per minute,at least twice a day. The ventilator rate was decreased morerapidly if tolerated by the patient, as reflected by clinicalassessment and blood gas monitoring. Patients who tolerateda ventilator rate of five breaths per minute for two hours withoutsigns of distress were extubated. A continuous positive airwaypressure of <5 cm of water was permitted.
Pressure-Support Ventilation
In the group that received pressure-support ventilation, pressurewas titrated to achieve a frequency of <25 breaths per minute.Pressure support was initially set at 18.0±6.1 cm ofwater, and we attempted to reduce this level of support by 2to 4 cm of water at least twice a day. The pace was increasedif the patient did not have signs of distress (the same criteriawere applied as in the initial trial of spontaneous breathing,except that a respiratory frequency of <25 breaths per minutewas required). Patients who tolerated pressure support at asetting of 5 cm of water for two hours with no apparent illeffects were extubated. A continuous positive airway pressureof <5 cm of water was permitted.
Intermittent Trials of Spontaneous Breathing
Patients assigned to intermittent trials of spontaneous breathingwere disconnected from the ventilator and allowed to breathespontaneously through either a T-tube circuit or a continuous-flowcircuit designed to provide a continuous positive airway pressureof <5 cm of water. The duration of the trials was graduallyincreased, and they were attempted at least twice a day. Betweenthe trials, assist–control ventilation was provided forat least one hour. Patients able to breathe on their own forat least two hours without signs of distress were extubated.
Once-Daily Trial of Spontaneous Breathing
Patients assigned to a once-daily trial of spontaneous breathingwere disconnected from the ventilator and allowed to breathespontaneously through a T-tube circuit for up to two hours eachday. If signs of intolerance developed, assist–controlventilation was reinstituted for 24 hours, at which time anothertrial was attempted. Patients who tolerated a two-hour trialwithout signs of distress were extubated.
For all four methods, weaning was considered to have failedif reintubation was necessary within 48 hours after extubationor if extubation was not possible after 14 days of weaning.Weaning was considered successful if extubation was achievedwithin the 14-day period and reintubation was not required within48 hours of extubation.
Statistical Analysis
The chi-square test was used to compare categorical data, andthe Kruskal–Wallis test was used to compare continuousvariables among the groups. The Kaplan–Meier method wasused to determine the probability of the success of a particularmethod of weaning over time.11 The relative probability of successover time was examined by a Cox proportional-hazards model.12Base-line covariates included in the model were the weaningtechnique, age, APACHE II score, ratio of PaO2 to FiO2, maximalinspiratory pressure, spontaneous respiratory frequency, spontaneoustidal volume per kilogram, duration of previous ventilator support,and the length of time to the failure of the initial trial ofspontaneous breathing. Backward elimination was used to reducethe model to the subgroup of factors that made statisticallysignificant contributions to variation in the time requiredfor successful weaning. Data were censored on 2 patients whodied during the study, 2 patients in whom weaning was interruptedbecause of intercurrent illness, 23 patients who required reintubationwithin 48 hours of extubation, and 11 patients who were stillreceiving ventilator support on day 14. We calculated that 31patients were needed in each group to detect at a power of 80percent a difference in weaning time between groups of two days,with a two-tailed alpha error of 0.05. Data are presented asmeans ±SD, medians, or proportions, as appropriate.
Results
Of the 546 study patients, 416 (76.2 percent) successfully underwenta two-hour trial of spontaneous breathing, and 372 (89.4 percent)of them were immediately extubated. Of these 372 patients, 58(15.6 percent) required reintubation within 48 hours. Extubationwas postponed for 24 hours in 44 patients, primarily becauseof concern about their ability to maintain clear airways. Thesepatients breathed through a T-tube circuit for up to 24 hours,but 16 (36.4 percent) required reinstitution of mechanical ventilationduring this period. The remaining 28 (63.6 percent) were extubatedwithin this 24-hour period, and only 2 required reintubationwithin the subsequent 48 hours.
One hundred thirty patients (23.8 percent) had signs of poortolerance during the initial trial of spontaneous breathing,which lasted a mean (±SD) of 50.1±31.2 minutes(range, 5 to 110). These patients were randomly assigned tointermittent mandatory ventilation (29 patients), pressure-supportventilation ( 37), intermittent trials of spontaneous breathing( 33) involving the use of a T-tube ( 27) or continuous positiveairway pressure (6) interspersed with assist–control ventilation,or a once-daily trial of spontaneous breathing alternating withassist–control ventilation ( 31). The groups were similarwith respect to the patients' characteristics, the indicationsfor mechanical ventilation, and respiratory function; the onlysignificant difference was in the duration of ventilatory supportbefore weaning was begun, which was shorter in the patientswho received intermittent mandatory ventilation than in theother groups (Table 1).
Table 1. Characteristics of the Study Population at Base Line.
Kaplan–Meier plots of the probability of successful weaningwith the use of each technique are shown in Figure 1, and theassociated median times to successful extubation are listed(with first and third quartiles) in Table 2. Cox proportional-hazardsregression analysis revealed four factors that predicted thetime required for successful weaning: age (P<0.02), the durationof ventilatory support before weaning was begun (P<0.005),the time to the failure of the first trial of spontaneous breathing(P<0.001), and weaning technique (Table 3). The adjustedrate of successful weaning was higher with a once-daily trialof spontaneous breathing than with intermittent mandatory ventilation(rate ratio, 2.83; 95 percent confidence interval, 1.36 to 5.89;P<0.006) or pressure-support ventilation (rate ratio, 2.05;95 percent confidence interval, 1.04 to 4.04; P<0.04) butnot significantly different from that with intermittent trialsof spontaneous breathing (rate ratio, 1.24; 95 percent confidenceinterval, 0.64 to 2.41; P = 0.54). The adjusted rate of successfulweaning with intermittent trials of spontaneous breathing washigher than that with intermittent mandatory ventilation (rateratio, 2.28; 95 percent confidence interval, 1.11 to 4.68; P= 0.024), but it was not significantly different from that withpressure-support ventilation (rate ratio, 1.66; 95 percent confidenceinterval, 0.87 to 3.16; P = 0.126). The adjusted rate of successfulweaning with pressure-support ventilation was not significantlydifferent from that with intermittent mandatory ventilation(rate ratio, 1.38; 95 percent confidence interval, 0.68 to 2.79;P = 0.32).
Figure 1. Kaplan–Meier Curves of the Probability of Successful Weaning with Intermittent Mandatory Ventilation, Pressure-Support Ventilation, Intermittent Trials of Spontaneous Breathing, and a Once-Daily Trial of Spontaneous Breathing.
After adjustment for base-line characteristics in a Cox proportional-hazards model, the rate of successful weaning with a once-daily trial of spontaneous breathing was 2.83 times higher than that with intermittent mandatory ventilation (P<0.006) and 2.05 times higher than that with pressure-support ventilation (P<0.04).
Table 3. Rate of Successful Weaning with the Various Techniques and According to Base-Line Characteristics.
Table 4 lists outcomes for the various techniques. More patientsin the group that received intermittent mandatory ventilationrequired continued ventilatory support on the 14th day thanin the groups that received once-daily trials (P = 0.07) orintermittent trials (P = 0.06) of spontaneous breathing. Therates of extubation and reintubation did not significantly differbetween the four groups.
Table 4. Outcomes in Patients Who Were Difficult to Wean from Mechanical Ventilation.
Discussion
This study has two major findings. First, in a selected groupof patients who were difficult to wean from mechanical ventilation,the rate of successful weaning depended on the technique employed:a once-daily trial of spontaneous breathing led to extubationabout three times more quickly than intermittent mandatory ventilationand about twice as quickly as pressure-support ventilation.There was no significant difference in the rate of success betweena once-daily trial and multiple daily trials of spontaneousbreathing or between intermittent mandatory ventilation andpressure-support ventilation. Second, ventilator support wasdiscontinued without any special weaning technique in two thirdsof an unselected group of patients, and only a small proportionrequired reintubation within 48 hours.
Intermittent Mandatory Ventilation
Several advantages have been claimed for intermittent mandatoryventilation as a weaning technique: it is supposed to preventa patient from "fighting" the ventilator, reduce respiratory-musclefatigue, and expedite weaning.4,13 However, there are few datato support these claims.14 Intermittent mandatory ventilationis usually delivered in a synchronized manner with demand-valvecircuitry, which increases the work of breathing.14,15 The intermittentnature of assistance also poses a problem. It was previouslyassumed that the degree of respiratory-muscle rest was proportionalto the level of machine assistance. However, recent evidenceindicates that respiratory-sensor output does not adjust tobreath-to-breath changes in respiratory load,16,17 and intermittentmandatory ventilation may therefore contribute to the developmentof respiratory-muscle fatigue or prevent recovery from it.
Studies of the efficacy of intermittent mandatory ventilationin weaning have serious limitations. Schachter et al.6 comparedit with conventional ventilation and noted no difference betweenthe two techniques in the duration of ventilator support. Theirstudy suffers from a retrospective design, nonuniform studygroups, and inadequate description of the protocol. Hastingset al.7 compared trials of spontaneous breathing with intermittentmandatory ventilation at a fixed rate (4 breaths per minute)in patients in stable condition after cardiac surgery. The lengthof time to extubation was similar in the two groups —approximately 2.6 hours. Their study provides little insight,however, because 24 hours had already elapsed since the operationand the patients had good pulmonary function; thus, little difficultyin weaning was anticipated. In patients in stable conditionwho received ventilator support for 3.6 days, Tomlinson et al.8found that the duration of weaning was similar with spontaneous-breathingtrials and intermittent mandatory ventilation — approximately5.6 hours. This study was weighted toward patients who receivedshort-term ventilatory support, and two thirds of those weanedwithin 2 hours were patients who received ventilatory supportfor less than 72 hours postoperatively.
In contrast, we studied difficult-to-wean patients who had receivedmechanical ventilation for 6.5±4.5 days. Although mostpatients could theoretically have met the extubation criteriawithin 24 hours of study entry, 17 percent were receiving ventilatorysupport after 14 days. Weaning took longer than in either ofthe trials of spontaneous breathing.7,8 Despite the use of randomization,the patients in the group assigned to intermittent mandatoryventilation had received ventilation for a shorter time thanthe patients in the other groups. This actually resulted ina bias in their favor, since weaning was accomplished more rapidlyin patients receiving short-term support.
Pressure-Support Ventilation
Pressure-support ventilation is commonly used to counteractthe work of breathing imposed by endotracheal tubes and ventilatorcircuits. Theoretically, this should help with weaning, becausea patient who is comfortable at the compensatory level of pressuresupport should be able to sustain ventilation after extubation.However, the level of pressure support necessary to eliminatethe work imposed by endotracheal tubes and ventilator circuitsvaries considerably (from 3 to 14 cm of water)18,19; thus, anyprediction of a patient's ability to sustain ventilation afterextubation is likely to be misleading.
Brochard et al.20 recently reported that the duration of weaningwas significantly shorter with pressure support (5.7±3.7days) than with intermittent mandatory ventilation (9.9±8.2days) or trials of spontaneous breathing (8.5±8.3 days).In contrast, we found that weaning with pressure-support ventilationtook longer than weaning with a once-daily trial of spontaneousbreathing and was not superior to weaning with intermittentmandatory ventilation. We suspect that the apparent superiorityof pressure support in the study by Brochard et al. was dueto the constrained manner in which they used other techniques.Patients had to tolerate an intermittent mandatory ventilationrate of <4 breaths per minute for at least 24 hours beforebeing extubated. This poses a considerable ventilatory challengeand is not the usual approach to this technique.3,4,14,21 Incontrast, we extubated patients when they tolerated a ventilatorrate of five breaths per minute for two hours. In the studyby Brochard et al., physicians could request up to three trialsof spontaneous breathing over a 24-hour period, each lasting2 hours, before deciding to extubate a patient. Again, thisis a considerable ventilatory challenge — especially inpatients who have already had difficulty in weaning. We considerthe findings of their study and ours to be complementary. Bothshow that the pace of weaning depends on the manner in whicha technique is employed. When intermittent mandatory ventilationand spontaneous-breathing trials are used in a constrained manner,weaning is slower than with pressure-support ventilation.20Weaning is expedited when a trial of spontaneous breathing isattempted once a day. In both studies, the results pertain tospecific regimens for each weaning technique and cannot be extrapolatedto other regimens using these techniques.
Trials of Spontaneous Breathing
Some physicians gradually increase the duration of spontaneous-breathingtrials while reinstituting mechanical ventilation between trials.Other physicians go directly from offering a high level of ventilatoryassistance to a trial of spontaneous breathing, and if the trialis successful, extubate the patient without any further weaning.In the present study, two thirds of the patients initially enrolledwere extubated after their first trial of spontaneous breathing.A once-daily trial of spontaneous breathing also allowed speedierweaning than approaches offering partial ventilatory support.This approach simplifies management, since a patient's abilityto breathe spontaneously without ventilatory support needs tobe assessed only once a day. In contrast, with intermittentmandatory ventilation and pressure-support ventilation, ventilatorsettings must be adjusted repeatedly and each adjustment isusually followed by an arterial-blood gas measurement.
An implied goal of the various weaning techniques is to reconditionrespiratory muscles that may have been weakened during the periodof mechanical ventilation. Theoretically, a once-daily trialof spontaneous breathing and a prolonged period of rest maybe the most effective method of eliciting adaptive changes.22,23This approach meets the three principal requirements of a conditioningprogram: overload, specificity, and reversibility.22 Duringthe trial, patients breathe against an elevated intrinsic load,thus satisfying the overload requirement. Specificity is alsosatisfied, in that the trial is an endurance stimulus and thedesired objective is enhanced endurance. Finally, the use ofa daily trial prevents regression of the adaptive changes. Itmust be emphasized that this reasoning is based on indirectevidence and that the effect of different weaning techniqueson respiratory-muscle reconditioning has not been investigated.
Supported in part by a grant from the Veterans Affairs ResearchService.
We are indebted to Amal Jubran, M.D., and Franco Laghi, M.D.,for their careful review of the manuscript; to Victor Abrairaand William Henderson, Ph.D., for review of the statisticalanalysis; and to Alejandro Fernandez for artwork.
* The other members of the Spanish Lung Failure CollaborativeGroup are listed in the Appendix.
Source Information
From the Hospital Universitario de Getafe, Madrid (A.E., F.F., I.A., M.A.C.); Loyola University, Chicago, and Hines Veterans Affairs Hospital, Hines, Ill. (M.J.T.); Hospital del Mar (J.F.S.) and Hospital Santa Creu i Sant Pau (I.V., S.B.), Barcelona, Spain; Hospital Parc Tauli, Sabadell, Spain (R.F.); Hospital Germans Trias i Pujol, Badalona, Spain (R.T.); Complejo Hospitalario de León, León, Spain (D.C.); Hospital General de Segovia, Segovia, Spain (S.M.); and Hospital del Río Ortega, Valladolid, Spain (J.B.).
Address reprint requests to Dr. Esteban at the Servicio de Cuidados Intensivos, Hospital Universitario de Getafe, Ctra. de Toledo km 12'500, 28905 Getafe, Madrid, Spain.
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Appendix
The other members of the Spanish Lung Failure CollaborativeGroup are as follows: F. del Nogal and A. Algora (Hospital SeveroOchoa, Leganés); E. Palazón and M. Cerón(Hospital Universitario de Murcia, Murcia); J. Ibañezand J.M. Raurich (Hospital Son Dureta, Palma de Mallorca); J.Gudín and J. Cebrián (Hospital La Fé, Valencia);G. González and J.A. Gómez Rubi (Hospital Virgende la Arrixaca, Murcia); F. Iturbe (Hospital Arnau de Vilanova,Lleida); A. Vazquez (Hospital del Mar, Barcelona); P. Saura(Hospital Parc Tauli, Sabadell); J. Gener (Hospital GermansTrias i Pujol, Badalona); D. Fontaneda (Complejo Hospitalariode León, León); V. Sagredo (Hospital General deSegovia, Segovia); and M.J. Prieto (Hospital del RíoOrtega, Valladolid) — all in Spain.
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