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Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

ABSTRACT: Importance:Daily spontaneous breathing trials (SBTs) are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration of SBT remain controversial. Objective:To evaluate the effect of an SBT consisting of 30 minutes of pressure support ventilation (an approach that is less demanding for patients) vs an SBT consisting of 2 hours of T-piece ventilation (an approach that is more demanding for patients) on rates of successful extubation. Design, Setting, and Participants:Randomized clinical trial conducted from January 2016 to April 2017 among 1153 adults deemed ready for weaning after at least 24 hours of mechanical ventilation at 18 intensive care units in Spain. Follow-up ended in July 2017. Interventions:Patients were randomized to undergo a 2-hour T-piece SBT (n?=?578) or a 30-minute SBT with 8-cm H2O pressure support ventilation (n?=?557). Main Outcome and Measures:The primary outcome was successful extubation (remaining free of mechanical ventilation 72 hours after first SBT). Secondary outcomes were reintubation among patients extubated after SBT; intensive care unit and hospital lengths of stay; and hospital and 90-day mortality. Results:Among 1153 patients who were randomized (mean age, 62.2 [SD, 15.7] years; 428 [37.1%] women), 1018 (88.3%) completed the trial. Successful extubation occurred in 473 patients (82.3%) in the pressure support ventilation group and 428 patients (74.0%) in the T-piece group (difference, 8.2%; 95% CI, 3.4%-13.0%; P?=?.001). Among secondary outcomes, for the pressure support ventilation group vs the T-piece group, respectively, reintubation was 11.1% vs 11.9% (difference, -0.8%; 95% CI, -4.8% to 3.1%; P?=?.63), median intensive care unit length of stay was 9 days vs 10 days (mean difference, -0.3 days; 95% CI, -1.7 to 1.1 days; P?=?.69), median hospital length of stay was 24 days vs 24 days (mean difference, 1.3 days; 95% CI, -2.2 to 4.9 days; P?=?.45), hospital mortality was 10.4% vs 14.9% (difference, -4.4%; 95% CI, -8.3% to -0.6%; P?=?.02), and 90-day mortality was 13.2% vs 17.3% (difference, -4.1% [95% CI, -8.2% to 0.01%; P?=?.04]; hazard ratio, 0.74 [95% CI, 0.55-0.99]). Conclusions and Relevance:Among patients receiving mechanical ventilation, a spontaneous breathing trial consisting of 30 minutes of pressure support ventilation, compared with 2 hours of T-piece ventilation, led to significantly higher rates of successful extubation. These findings support the use of a shorter, less demanding ventilation strategy for spontaneous breathing trials. Trial Registration:ClinicalTrials.gov Identifier: NCT02620358.

SUBMITTER: Subira C

PROVIDER: S-EPMC6563557 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

Subirà Carles C Hernández Gonzalo G Vázquez Antònia A Rodríguez-García Raquel R González-Castro Alejandro A García Carolina C Rubio Olga O Ventura Lara L López Alexandra A de la Torre Maria-Carmen MC Keough Elena E Arauzo Vanesa V Hermosa Cecilia C Sánchez Carmen C Tizón Ana A Tenza Eva E Laborda César C Cabañes Sara S Lacueva Victoria V Del Mar Fernández Maria M Arnau Anna A Fernández Rafael R

JAMA 20190601 22

<h4>Importance</h4>Daily spontaneous breathing trials (SBTs) are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration of SBT remain controversial.<h4>Objective</h4>To evaluate the effect of an SBT consisting of 30 minutes of pressure support ventilation (an approach that is less demanding for patients) vs an SBT consisting of 2 hours of T-piece ventilation (an approach that is more demanding for patients) on rates of succe ...[more]

PMID: 31184740

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Project description:BackgroundRecent guidelines recommended conducting spontaneous breathing trial (SBT) with modest inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. However, it was based on few studies focused on the outcomes of extubation rather than the weaning process, despite the existence of various weaning situations in clinical practice. This study was designed to investigate the effects of SBT with pressure support ventilation (PSV) or T-piece on weaning outcomes.MethodsAll consecutive patients admitted to two medical intensive care units (ICUs) and those requiring mechanical ventilation (MV) for more than 24 h from November 1, 2017 to September 30, 2020 were prospectively registered. T-piece trial was used until March 2019, and then, pressure support of 8 cmH2O and 0 positive end-expiratory pressure were used for SBT since July 2019, after a 3-month transition period for the revised SBT protocol. The primary outcome of this study was successful weaning defined according to the WIND (Weaning according to a New Definition) definition and were compared between the T-piece group and PSV group. The association between the SBT method and weaning outcome was evaluated with logistic regression analysis.ResultsIn this study, 787 eligible patients were divided into the T-piece (n = 473) and PSV (n = 314) groups after excluding patients for a 3-month transition period. Successful weaning was not different between the two groups (85.0% vs. 86.3%; p = 0.607). However, the PSV group had a higher proportion of short weaning (70.1% vs. 59.0%; p = 0.002) and lower proportion of difficult weaning (13.1% vs. 24.1%; p < 0.001) than the T-piece group. The proportion of prolonged weaning was similar between the two groups (16.9% vs. 16.9%; p = 0.990). After excluding patients who underwent tracheostomy before the SBTs, similar results were found. Reintubation rates at 48 h, 72 h, and 7 days following the planned extubation were not different between the PSV and T-piece groups. Moreover, no significant differences in intensive care unit and hospital mortality and length of stay were observed.ConclusionsIn critically ill medical patients, SBT using PSV was not associated with a higher rate of successful weaning compared with SBT using T-piece. However, PSV could shorten the weaning process without increasing the risk of reintubation.

Project description:BackgroundA spontaneous breathing trial (SBT) is used to determine whether patients are ready for extubation, but the best method for choosing the SBT strategy remains controversial. We investigated the effect of high-flow oxygen versus T-piece ventilation strategies during SBT on rates of weaning failure among patients receiving mechanical ventilation.MethodsThis randomized clinical trial was conducted from June 2019 through January 2022 among patients receiving mechanical ventilation for ≥ 12 h who fulfilled the weaning readiness criteria at a single-center medical intensive care unit. Patients were randomized to undergo either T-piece SBT or high-flow oxygen SBT. The primary outcome was weaning failure on day 2, and the secondary outcomes were weaning failure on day 7, ICU and hospital length of stay, and ICU and in-hospital morality.ResultsOf 108 patients (mean age, 67.0 ± 11.1 years; 64.8% men), 54 received T-piece SBT and 54 received high-flow oxygen SBT. Weaning failure on day 2 occurred in 5 patients (9.3%) in the T-piece group and 3 patients (5.6%) in the high-flow group (difference, 3.7% [95% CI, - 6.1-13.6]; p = 0.713). Weaning failure on day 7 occurred in 13 patients (24.1%) in the T-piece group and 7 patients (13.0%) in the high-flow group (difference, 11.1% [95% CI, - 3.4-25.6]; p = 0.215). A post hoc subgroup analysis showed that high-flow oxygen SBT was significantly associated with a lower rate of weaning failure on day 7 (OR, 0.17 [95% CI, 0.04-0.78]) among those patients intubated because of respiratory failure (p for interaction = 0.020). The ICU and hospital length of stay and mortality rates did not differ significantly between the two groups. During the study, no serious adverse events were recorded.ConclusionsAmong patients receiving mechanical ventilation, high-flow oxygen SBT did not significantly reduce the risk of weaning failure compared with T-piece SBT. However, the study may have been underpowered to detect a clinically important treatment effect for the comparison of high-flow oxygen SBT versus T-piece SBT, and a higher percentage of patients with simple weaning and a lower weaning failure rate than expected should be considered when interpreting the findings. Clinical trial registration This trial was registered with ClinicalTrials.gov (number NCT03929328) on April 26, 2019.

Project description:IntroductionIn intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.Methods and analysisThis study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.Ethics and disseminationThe study has been approved by the central ethics committee 'Ile de France V' (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04227639.

Project description:To determine the feasibility of delivering inhaled treprostinil during mechanical ventilation and spontaneous unassisted ventilation using the Tyvaso Inhalation System and the vibrating mesh nebulizer. We sought to compare differences in fine particle fraction, and absolute inhaled treprostinil mass delivered to neonatal, pediatric, and adult models affixed with a face mask, conventional, and high-frequency ventilation between Tyvaso Inhalation System and with different nebulizer locations between Tyvaso Inhalation System and vibrating mesh nebulizer.Fine particle fraction was first determined via impaction with both the Tyvaso Inhalation System and vibrating mesh nebulizer. Next, a test lung configured with neonatal, pediatric, and adult mechanics and a filter to capture medication was attached to a realistic face model during spontaneous breathing or an endotracheal tube during conventional ventilation and high-frequency oscillator ventilator. Inhaled treprostinil was then nebulized with both the Tyvaso Inhalation System and vibrating mesh nebulizer, and the filter was analyzed via high-performance liquid chromatography. Testing was done in triplicate. Independent two-sample t tests were used to compare mean fine particle fraction and inhaled mass between devices. Analysis of variance with Tukey post hoc tests were used to compare within device differences.Academic children's hospital aerosol research laboratory.Fine particle fraction was not different between the Tyvaso Inhalation System and vibrating mesh nebulizer (0.78?±?0.04 vs 0.77?±?0.08, respectively; p = 0.79). The vibrating mesh nebulizer delivered the same or greater inhaled treprostinil than the Tyvaso Inhalation System in every simulated model and condition. When using the vibrating mesh nebulizer, delivery was highest when using high-frequency oscillator ventilator in the neonatal and pediatric models, and with the nebulizer in the distal position in the adult model.The vibrating mesh nebulizer is a suitable alternative to the Tyvaso Inhalation System for inhaled treprostinil delivery. Fine particle fraction is similar between devices, and vibrating mesh nebulizer delivery meets or exceeds delivery of the Tyvaso Inhalation System. Delivery for infants and children during high-frequency oscillator ventilator with the vibrating mesh nebulizer may result in higher than expected dosages.

Dataset Information

Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

Publications

Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

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