Which spontaneous breathing trial to predict effort to breathe after extubation according to five critical illnesses: the cross-over GLOBAL WEAN study protocol

Abstract

Introduction: Readiness to be freed from ventilatory support can be evaluated by spontaneous breathing trial (SBT) assessing the patient's ability to sustain respiratory effort after extubation. Current SBT practices are heterogenous and there are few physiological studies on the topic. The objective of this study is to assess which SBT best reproduces inspiratory effort to breathe after extubation depending on the patient's illness.

Methods and analysis: This will be a multicentre randomised cross-over physiological study, in a large population, in the era of modern intensive care units using last generation modern ventilators. Each included patient will perform three 15-minute SBTs in a random order: pressure support ventilation (PSV) level of 7 cmH₂O with positive end expiratory pressure (PEEP) level of 0 cmH₂O, PSV 0 cmH₂O with PEEP 0 cmH₂O and T-piece trial. A rest period of baseline state ventilation will be observed between the SBTs (10 min) and before extubation (30 min). Primary outcome will be the inspiratory muscle effort, reflected by pressure time product per minute (PTPmin). This will be calculated from oesophageal pressure measurements at baseline state, before and after each SBT and 20 min after extubation. Secondary outcomes will be PTPmin at 24 hours and 48 hours after extubation, changes in physiological variables and respiratory parameters at each step, postextubation respiratory management and the rate of successful extubation. One hundred patients with at least 24 hours of invasive mechanical ventilation will be analysed, divided into five categories of critical illness: abdominal surgery, brain injury, chest trauma, chronic obstructive pulmonary disease and miscellaneous (pneumonia, sepsis, heart disease).

Ethics and dissemination: The study project was approved by the appropriate ethics committee (2019-A01063-54, Comité de Protection des Personnes TOURS - Région Centre - Ouest 1, France). Informed consent is required, for all patients or surrogate in case of inability to give consent.

Trial registration number: NCT04222569.

Keywords: adult intensive & critical care; rehabilitation medicine; respiratory physiology.

Figure 1

Consolidated Standards of Reporting Trial (CONSORT) diagram of the GLOBAL WEAN study. ICU, intensive care unit; SBT, spontaneous breathing trial.

Figure 2

Study design and timeline of data collection. CPAP, continuous positive airway pressure; PSV, pressure support ventilation; SBT, spontaneous breathing trial.