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April 23, 2026BMJ OpenOpen Access

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

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Authors

EMEuan J. McCaugheyAMA.J. MclachlanJCJason Cai

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Overview

Trial evaluates functional electrical stimulation's effect on weaning success in critically ill patients, indicating potential for improved outcomes.

Key Points

  • The aim is to assess whether abdominal functional electrical stimulation shortens mechanical ventilation duration in critically ill patients.
  • Multicentre, double-blinded, sham-controlled trial across 30 ICUs in multiple countries.
  • Participants aged 22+ with 24–96 hours of mechanical ventilation will be enrolled until 150 successful liberations are achieved.
  • Randomised 1:1 to receive active stimulation or sham, two times daily for a maximum of 28 days.
  • Primary outcome is successful liberation time from mechanical ventilation after intervention.
  • Secondary outcomes include cough peak flow and maximum expiratory pressure at 24 hours post-extubation and overall ICU duration.
  • Potential improvement in patient-centered outcomes in intensive care settings.

Cite This Study

McCaughey et al. (2026) studied this question.

synapsesocial.com/papers/69e9b9a285696592c86ec438https://doi.org/10.1136/bmjopen-2025-113540
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