Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial

Introduction Nearly half of patients who receive invasive mechanical ventilation for acute respiratory failure require over 4 days of ventilator support, each day of which is associated with increased morbidity, mortality and cost. Many of these patients develop expiratory muscle atrophy and weakness, which are linked to failed extubation and weaning.

We seek to test the hypothesis that exhalation synchronised abdominal functional electrical stimulation reduces mechanical ventilation duration. Methods and analysis This pivotal superiority trial will be performed in up to 30 intensive care units (ICUs) in the USA, France, the Netherlands and Australia.

Adults (≥22 years old) who have been mechanically ventilated for 24 - 96 hours and are expected to remain ventilated for another 24+ hours are potentially eligible. We will recruit participants until 150 successful liberations from mechanical ventilation occur.

To achieve this, we estimate that a maximum of 272 participants will be randomised in a 1:1 ratio to receive 30 min of active exhalation synchronised abdominal functional electrical stimulation (vs sham).