Pressure support and positive end-expiratory pressure versus T-piece during spontaneous breathing trial in difficult weaning from mechanical ventilation: study protocol for the SBT-ICU study

Abstract

Background Spontaneous breathing trials are performed in critically ill intubated patients in order to assess readiness to be weaned from mechanical ventilation. In patients with difficult weaning (i.e. not extubated after their first SBT), performing SBT using pressure support with or without positive end-expiratory pressure or using T-piece is debated. As ventilatory support during SBT is greater on pressure support than on T-piece and as positive end-expiratory pressure can prevent weaning-induced pulmonary oedema, we hypothesized that their combination and large use of post-extubation non-invasive ventilation may shorten the time until successful extubation as compared with T-piece, without increasing the rate of reintubation. Methods SBT-ICU is a monocentric prospective open labelled, randomized controlled superiority trial comparing two mechanical ventilation weaning strategies; i.e. daily spontaneous breathing trials using pressure support with positive end-expiratory pressure or T-piece. The primary outcome will be time until successful extubation (defined by as extubation, without reintubation or death within the seven following days). Discussion This paper describes the protocol of the SBT-ICU trial. Enrolment of patients in the study is ongoing. Trial registration ClinicalTrials.gov NCT03861117. Registered on March 1, 2019, before the beginning of inclusion.

Liberation from mechanical ventilation in critically ill patients: Korean Society of Critical Care Medicine Clinical Practice Guidelines

“…Therefore, we suggest that the proper method of SBT should be decided individually based on each patient’s condition, as assessed in a careful evaluation by the clinician. Furthermore, these recommendations might change depending on the results of an ongoing, large-scale RCT [ 52 ].…”

Spontaneous breathing trial with pressure support on positive end-expiratory pressure and extensive use of non-invasive ventilation versus T-piece in difficult-to-wean patients from mechanical ventilation: a randomized controlled trial

“…The study was a monocentric prospective open label, randomized controlled superiority trial with 2 parallel groups and balanced randomization with a 1:1 ratio. The trial protocol was previously published [ 7 ]. The study was conducted in one ICU located in a French academic hospital and was registered at clinicalTrials.gov (NCT03861117) before the inclusion of the first patient.…”

“…Prespecified secondary outcomes were the following: rate of successful extubation on the first extubation attempt; invasive mechanical ventilation duration (after inclusion); mechanical (invasive and non-invasive) ventilation duration after inclusion; ventilator-free days at day-28 and day-90; ICU and hospital length of stay after inclusion; ICU, day-28 and day-90 mortality; and reintubation rate. Minor modifications occurred to some secondary outcomes after trial onset and before database lock to improve reproducibility with comparable studies [ 7 ]. Computation of reintubation rate was modified and post hoc additional outcomes were added during the reviewing process (Additional file 8 ).…”