Trials directly comparing alternative spontaneous breathing trial techniques: a systematic review and meta-analysis.
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ABSTRACT: Background
The effect of alternative spontaneous breathing trial (SBT) techniques on extubation success and other clinically important outcomes is uncertain.Methods
We searched MEDLINE, EMBASE, CENTRAL, CINAHL, Evidence-Based Medicine Reviews, Ovid Health Star, proceedings of five conferences (1990-2016), and reference lists for randomized trials comparing SBT techniques in intubated adults or children. Primary outcomes were initial SBT success, extubation success, or reintubation. Two reviewers independently screened citations, assessed trial quality, and abstracted data.Results
We identified 31 trials (n = 3541 patients). Moderate-quality evidence showed that patients undergoing pressure support (PS) compared with T-piece SBTs (nine trials, n = 1901) were as likely to pass an initial SBT (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.89-1.11; I 2 = 77%) but more likely to be ultimately extubated successfully (RR 1.06, 95% CI 1.02-1.10; 11 trials, n = 1904; I 2 = 0%). Exclusion of one trial with inconsistent results for SBT and extubation outcomes suggested that PS (vs T-piece) SBTs also improved initial SBT success (RR 1.06, 95% CI 1.01-1.12; I 2 = 0%). Limited data suggest that automatic tube compensation plus continuous positive airway pressure (CPAP) vs CPAP alone or PS increase SBT but not extubation success.Conclusions
Patients undergoing PS (vs T-piece) SBTs appear to be 6% (95% CI 2-10%) more likely to be extubated successfully and, if the results of an outlier trial are excluded, 6% (95% CI 1-12%) more likely to pass an SBT. Future trials should investigate patients for whom SBT and extubation outcomes are uncertain and compare techniques that maximize differences in support.
SUBMITTER: Burns KEA
PROVIDER: S-EPMC5455092 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background: Spontaneous breathing trial (SBT) has been used to predict the optimal time of weaning from ventilator. However, it remains controversial which trial should be preferentially selected. We aimed to compare and rank four common SBT modes including automatic tube compensation (ATC), pressure support ventilation (PSV), continuous positive airway pressure (CPAP), and T-piece among critically ill patients receiving mechanical ventilation (MV). Methods: We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify studies that investigated the comparative efficacy and safety of at least two SBT strategies among critically ill patients up to May 17, 2020. We estimated the surface under the cumulative ranking curve (SUCRA) to rank SBT techniques, and determined the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation method. Primary outcome was weaning success. Secondary outcomes were reintubation, SBT success, duration of acute care, and intensive care unit (ICU) mortality. Statistical analysis was conducted by using RevMan 5.4, Stata, and R software. Results: We enrolled 24 trials finally. Extubation success rate was significantly higher in ATC than that in T-piece (OR, 0.28; 95% CI, 0.13-0.64) or PSV (OR, 0.53; 95% CI, 0.32-0.88). For SBT success, ATC was better than other SBT techniques, with a pooled OR ranging from 0.17 to 0.42. For reintubation rate, CPAP was worse than T-piece (OR, 2.76; 95% CI, 1.08 to 7.06). No significant difference was detected between SBT modes for the length of stay in ICU or long-term weaning unit (LWU). Similar result was also found for ICU mortality between PSV and T-piece. Majority direct results were confirmed by network meta-analysis. Besides, ATC ranks at the first, first, and fourth place with a SUCRA of 91.7, 99.7, and 39.9%, respectively in increasing weaning success and SBT success and in prolonging ICU or LWU length of stay among four SBT strategies. The confidences in evidences were rated as low for most comparisons. Conclusion: ATC seems to be the optimal choice of predicting successful weaning from ventilator among critically ill patients. However, randomized controlled trials (RCTs) with high quality are needed to further establish these findings.
| S-EPMC8647911 | biostudies-literature
Project description:BackgroundImmobilization of the cervical spine worsens tracheal intubation conditions. Various intubation devices have been tested in this setting. Their relative usefulness remains unclear.MethodsWe searched MEDLINE, EMBASE, and the Cochrane Library for randomized controlled trials comparing any intubation device with the Macintosh laryngoscope in human subjects with cervical spine immobilization. The primary outcome was the risk of tracheal intubation failure at the first attempt. Secondary outcomes were quality of glottis visualization, time until successful intubation, and risk of oropharyngeal complications.ResultsTwenty-four trials (1866 patients) met inclusion criteria. With alternative intubation devices, the risk of intubation failure was lower compared with Macintosh laryngoscopy [risk ratio (RR) 0.53; 95% confidence interval (CI) 0.35-0.80]. Meta-analyses could be performed for five intubation devices (Airtraq, Airwayscope, C-Mac, Glidescope, and McGrath). The Airtraq was associated with a statistically significant reduction of the risk of intubation failure at the first attempt (RR 0.14; 95% CI 0.06-0.33), a higher rate of Cormack-Lehane grade 1 (RR 2.98; 95% CI 1.94-4.56), a reduction of time until successful intubation (weighted mean difference -10.1 s; 95% CI -3.2 to -17.0), and a reduction of oropharyngeal complications (RR 0.24; 95% CI 0.06-0.93). Other devices were associated with improved glottis visualization but no statistically significant differences in intubation failure or time to intubation compared with conventional laryngoscopy.ConclusionsIn situations where the spine is immobilized, the Airtraq device reduces the risk of intubation failure. There is a lack of evidence for the usefulness of other intubation devices.
| S-EPMC4681615 | biostudies-literature
Project description:Background Bifurcation lesions account for 20% of all percutaneous coronary interventions and represent a complex subset which are associated with lower procedural success and higher rates of restenosis. The ideal bifurcation technique, however, remains elusive. Methods and Results Extensive search of the literature was performed to pull data from randomized clinical trials that met predetermined inclusion criteria. Conventional meta-analysis produced pooled relative risk (RR) and 95% CI of 2-stent technique versus provisional stent on prespecified outcomes. Both frequentist and Bayesian network meta-analyses were performed to compare bifurcation techniques. A total of 8318 patients were included from 29 randomized clinical trials. Conventional meta-analysis showed no significant differences in all-cause mortality, cardiac death, major adverse cardiac events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization between 2-stent techniques and provisional stenting. Frequentist network meta-analysis revealed that double kissing crush was associated with lower cardiac death (RR, 0.57; 95% CI, 0.38-0.84), major adverse cardiac events (RR, 0.50; 95% CI, 0.39-0.64), myocardial infarction (RR, 0.60; 95% CI, 0.39-0.90), stent thrombosis (RR, 0.50; 95% CI, 0.28-0.88), target lesion revascularization, and target vessel revascularization when compared with provisional stenting. Double kissing crush was also superior to other 2-stent techniques, including T-stent or T and protrusion, dedicated bifurcation stent, and culotte. Conclusions Double kissing crush was associated with lower risk of cardiac death, major adverse cardiac events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization compared with provisional stenting and was superior to other 2-stent techniques. Superiority of 2-stent strategy over provisional stenting was observed in subgroup meta-analysis stratified to side branch lesion length ≥10 mm.
| S-EPMC9238651 | biostudies-literature
Project description:ImportanceSpontaneous breathing trials (SBTs) are used to determine extubation readiness in extremely preterm neonates (gestational age ≤28 weeks), but these trials rely on empirical combinations of clinical events during endotracheal continuous positive airway pressure (ET-CPAP).ObjectivesTo describe clinical events during ET-CPAP and to assess accuracy of comprehensive clinical event combinations in predicting successful extubation compared with clinical judgment alone.Design, setting, and participantsThis multicenter diagnostic study used data from 259 neonates seen at 5 neonatal intensive care units from the prospective Automated Prediction of Extubation Readiness (APEX) study from September 1, 2013, through August 31, 2018. Neonates with birth weight less than 1250 g who required mechanical ventilation were eligible. Neonates deemed to be ready for extubation and who underwent ET-CPAP before extubation were included.InterventionsIn the APEX study, cardiorespiratory signals were recorded during 5-minute ET-CPAP, and signs of clinical instability were monitored.Main outcomes and measuresFour clinical events were documented during ET-CPAP: apnea requiring stimulation, presence and cumulative durations of bradycardia and desaturation, and increased supplemental oxygen. Clinical event occurrence was assessed and compared between extubation pass and fail (defined as reintubation within 7 days). An automated algorithm was developed to generate SBT definitions using all clinical event combinations and to compute diagnostic accuracies of an SBT in predicting extubation success.ResultsOf 259 neonates (139 [54%] male) with a median gestational age of 26.1 weeks (interquartile range [IQR], 24.9-27.4 weeks) and median birth weight of 830 g (IQR, 690-1019 g), 147 (57%) had at least 1 clinical event during ET-CPAP. Apneas occurred in 10% (26 of 259) of neonates, bradycardias in 19% (48), desaturations in 53% (138), and increased oxygen needs in 41% (107). Neonates with successful extubation (71% [184 of 259]) had significantly fewer clinical events (51% [93 of 184] vs 72% [54 of 75], P = .002), shorter cumulative bradycardia duration (median, 0 seconds [IQR, 0 seconds] vs 0 seconds [IQR, 0-9 seconds], P < .001), shorter cumulative desaturation duration (median, 0 seconds [IQR, 0-59 seconds] vs 25 seconds [IQR, 0-90 seconds], P = .003), and less increase in oxygen (median, 0% [IQR, 0%-6%] vs 5% [0%-18%], P < .001) compared with neonates with failed extubation. In total, 41 602 SBT definitions were generated, demonstrating sensitivities of 51% to 100% (median, 96%) and specificities of 0% to 72% (median, 22%). Youden indices for all SBTs ranged from 0 to 0.32 (median, 0.17), suggesting low accuracy. The SBT with highest Youden index defined SBT pass as having no apnea (with desaturation requiring stimulation) or increase in oxygen requirements by 15% from baseline and predicted extubation success with a sensitivity of 93% and a specificity of 39%.Conclusions and relevanceThe findings suggest that extremely preterm neonates commonly show signs of clinical instability during ET-CPAP and that the accuracy of multiple clinical event combinations to define SBTs is low. Thus, SBTs may provide little added value in the assessment of extubation readiness.
| S-EPMC6990705 | biostudies-literature
Project description:OBJECTIVE:Randomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients' preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined. DESIGN:Systematic review and meta-analyses. DATA SOURCES:MEDLINE, Embase, PsycINFO and the Cochrane Library. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:RPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included. DATA EXTRACTION AND SYNTHESIS:Two independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed. RESULTS:In total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%-100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%-99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI -0.178 to 0.364, p=0.502). CONCLUSIONS:Patients' preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs. PROSPERO REGISTRATION NUMBER:CRD42019094438.
| S-EPMC6797441 | biostudies-other
Project description:Predicting whether an obese critically ill patient can be successfully extubated may be specially challenging. Several weaning tests have been described but no physiological study has evaluated the weaning test that would best reflect the post-extubation inspiratory effort.This was a physiological randomized crossover study in a medical and surgical single-center Intensive Care Unit, in patients with body mass index (BMI) >35 kg/m2 who were mechanically ventilated for more than 24 h and underwent a weaning test. After randomization, 17 patients were explored using five settings : pressure support ventilation (PSV) 7 and positive end-expiratory pressure (PEEP) 7 cmH2O; PSV 0 and PEEP 7cmH2O; PSV 7 and PEEP 0 cmH2O; PSV 0 and PEEP 0 cmH2O; and a T piece, and after extubation. To further minimize interaction between each setting, a period of baseline ventilation was performed between each step of the study. We hypothesized that the post-extubation work of breathing (WOB) would be similar to the T-tube WOB.Respiratory variables and esophageal and gastric pressure were recorded. Inspiratory muscle effort was calculated as the esophageal and trans-diaphragmatic pressure time products and WOB. Sixteen obese patients (BMI 44 kg/m2?±?8) were included and successfully extubated. Post-extubation inspiratory effort, calculated by WOB, was 1.56 J/L?±?0.50, not statistically different from the T piece (1.57 J/L?±?0.56) or PSV 0 and PEEP 0 cmH2O (1.58 J/L?±?0.57), whatever the index of inspiratory effort. The three tests that maintained pressure support statistically underestimated post-extubation inspiratory effort (WOB 0.69 J/L?±?0.31, 1.15 J/L?±?0.39 and 1.09 J/L?±?0.49, respectively, p?<?0.001). Respiratory mechanics and arterial blood gases did not differ between the five tests and the post-extubation condition.In obese patients, inspiratory effort measured during weaning tests with either a T-piece or a PSV 0 and PEEP 0 was not different to post-extubation inspiratory effort. In contrast, weaning tests with positive pressure overestimated post-extubation inspiratory effort.Clinical trial.gov (reference NCT01616901 ), 2012, June 4th.
| S-EPMC5081985 | biostudies-literature
Project description:Inspiratory fall in intrathoracic pressure during a spontaneous breathing trial (SBT) may precipitate cardiac dysfunction and acute pulmonary edema. We aimed to determine the relationship between radiological signs of pulmonary congestion prior to an SBT and weaning outcomes. This was a post hoc analysis of a prospective cohort study involving patients in an adult medical-surgical ICU. All enrolled individuals met the eligibility criteria for liberation from mechanical ventilation. Tracheostomized subjects were excluded. The primary endpoint was SBT failure, defined as the inability to tolerate a T-piece trial for 30-120 min. An attending radiologist applied a radiological score on interpretation of digital chest X-rays performed before the SBT. A total of 170 T-piece trials were carried out; SBT failure occurred in 28 trials (16.4%), and 133 subjects (78.3%) were extubated at first attempt. Radiological scores were similar between SBT-failure and SBT-success groups (median [interquartile range] = 3 [2-4] points vs. 3 [2-4] points; p = 0.15), which, according to the score criteria, represented interstitial lung congestion. The analysis of ROC curves demonstrated poor accuracy (area under the curve = 0.58) of chest x-rays findings of congestion prior to the SBT for discriminating between SBT failure and SBT success. No correlation was found between fluid balance in the 48 h preceding the SBT and radiological score results (ρ = -0.13). Radiological findings of pulmonary congestion should not delay SBT indication, given that they did not predict weaning failure in the medical-surgical critically ill population. (ClinicalTrials.gov identifier: NCT02022839 [http://www.clinicaltrials.gov/]).
| S-EPMC5687960 | biostudies-literature
Project description:BACKGROUND:Little is known about the best strategy for weaning patients with chronic obstructive pulmonary disease (COPD) from mechanical ventilation. Spontaneous breathing trials (SBT) using a T-piece or pressure-support ventilation (PSV) have a central role in this process. Our aim was to compare T-piece and PSV SBTs according to the duration of mechanical ventilation (MV) in patients with COPD. METHODS:Patients with COPD who had at least 48 hours of invasive MV support were randomized to 30 minutes of T-piece or PSV at 10 cm H2O after being considered able to undergo a SBT. All patients were preemptively connected to non-invasive ventilation after extubation. Tracheostomized patients were excluded. The primary outcome was total invasive MV duration. Time to liberation from MV was assessed as secondary outcome. RESULTS:Between 2012 and 2016, 190 patients were randomized to T-piece (99) or PSV (91) groups. Extubation at first SBT was achieved in 78% of patients. The mean total MV duration was 10.82 ± 9.1 days for the T-piece group and 7.31 ± 4.9 days for the PSV group (p < 0.001); however, the pre-SBT duration also differed (7.35 ± 3.9 and 5.84 ± 3.3, respectively; p = 0.002). The time to liberation was 8.36 ± 11.04 days for the T-piece group and 4.06 ± 4.94 for the PSV group (univariate mean ratio = 2.06 [1.29-3.27], p = 0.003) for the subgroup of patients with difficult or prolonged weaning. The study group was independently associated with the time to liberation in this subgroup. CONCLUSIONS:The SBT technique did not influence MV duration for patients with COPD. For the difficult/prolonged weaning subgroup, the T-piece may be associated with a longer time to liberation, although this should be clarified by further studies. TRIAL REGISTRATION:ClinicalTrials.gov NCT01464567, at November 3, 2011.
| S-EPMC6107186 | biostudies-literature
Project description:BackgroundThe socket seal surgery (SSS) technique is a common alternative for the management of the post-extraction sockets that requires a primary closure of the wound to promote proper regeneration and ridge preservation.ObjectiveTo learn about the effect of different SSS techniques on alveolar ridge preservation MATERIAL AND METHODS: Two independent and calibrated reviewers conducted an electronic search in PubMed, Cochrane, and Web of Science for randomized clinical trials (RCT) published up to June 2020. The evaluation of the risk of bias in the included studies was carried out following the Cochrane manual for interventions of systematic reviews, version 5.1.0. A meta-analysis of ridge width changes at - 1, - 3, and - 5 mm cutoff points from bone crest was conducted using a random-effects model. The risk of types I and II errors against accrued data was appraised obtaining the required information size using a trial sequential analysis package (TSA).ResultsA total of 135 sockets located in the esthetic zone were evaluated with a minimum of a 3-month follow-up after tooth extraction in 6 RCTs. The evaluated SSS techniques were free gingival graft (FGG), collagen matrix (CM), collagen sponge (CS), acellular dermal matrix (ADM), and polytetrafluoroethylene membrane (PTFEm). The FGG in sockets without bone filling showed significant results in preserving both buccal and lingual bone height (- 1.42 mm in the experimental group versus - 0.01 in the control group). The comparison of CM and FGG with bone filling did not show clinical differences in terms of dimensional bone changes. No clinical differences were found in either width or gingival thickness when comparing CM and CS. The meta-analyses of RW changes comparing CM versus FGG showed no significant differences, but a trend for lessening horizontal reduction at - 1, - 3, and - 5 mm in favor of FGG. The TSA showed that accrued data did not reach the required information size, and more evidence is required for clinical significance inferences.ConclusionsThere are several predictable SSS techniques to improve clinical results in ridge preservation. More clinical studies in the form of clinical trials are required to demonstrate the superiority of one technique over another.
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Project description:Neurally Adjusted Ventilatory Assist (NAVA) is a proportional ventilatory mode that uses the electrical activity of the diaphragm (EAdi) to offer ventilatory assistance in proportion to patient effort. NAVA has been increasingly used for critically ill patients, but it has not been evaluated during spontaneous breathing trials (SBT). We designed a pilot trial to assess the feasibility of using NAVA during SBTs, and to compare the breathing pattern and patient-ventilator asynchrony of NAVA with Pressure Support (PSV) during SBTs.We conducted a crossover trial in the ICU of a university hospital in Brazil and included mechanically ventilated patients considered ready to undergo an SBT on the day of the study. Patients underwent two SBTs in randomized order: 30 min in PSV of 5 cmH2O or NAVA titrated to generate equivalent peak airway pressure (Paw), with a positive end-expiratory pressure of 5 cmH2O. The ICU team, blinded to ventilatory mode, evaluated whether patients passed each SBT. We captured flow, Paw and electrical activity of the diaphragm (EAdi) from the ventilator and used it to calculate respiratory rate (RR), tidal volume (VT), and EAdi. Detection of asynchrony events used waveform analysis and we calculated the asynchrony index as the number of asynchrony events divided by the number of neural cycles.We included 20 patients in the study. All patients passed the SBT in PSV, and three failed the SBT in NAVA. Five patients were reintubated and the extubation failure rate was 25% (95% CI 9-49%). Respiratory parameters were similar in the two modes: VT = 6.1 (5.5-6.5) mL/Kg in NAVA vs. 5.5 (4.8-6.1) mL/Kg in PSV (p = 0.076) and RR = 27 (17-30) rpm in NAVA vs. 26 (20-30) rpm in PSV, p = 0.55. NAVA reduced AI, with a median of 11.5% (4.2-19.7) compared to 24.3% (6.3-34.3) in PSV (p = 0.033).NAVA reduces patient-ventilator asynchrony index and generates a respiratory pattern similar to PSV during SBTs. Patients considered ready for mechanical ventilation liberation may be submitted to an SBT in NAVA using the same objective criteria used for SBTs in PSV.ClinicalTrials.gov ( NCT01337271 ), registered April 12, 2011.
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