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RESCUE 3

Title A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3)
Therapeutic Area Intensive Care
Principal Investigator Sadeq Quraishi, MD
Min Age 18 Years
Gender All
Contact Iwona Bonney
617 636 9322
ibonney@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03783884

Overview

A randomized, controlled, open-label, multi-center adaptive clinical trial to investigate the safe and effective performance of the Lungpacer Diaphragm Pacing Therapy System in patients who have failed to wean from mechanical ventilation

Study Details

Inclusion Criteria

  • Have been mechanically ventilated for ≥96 hours (4 days), and,
  • Have satisfied the Readiness-to-Wean criteria, and,
  • Have failed at least 2 weaning attempts from mechanical ventilation

Exclusion Criteria

  • MIP (absolute value) >50 cm H2O; BMI >45 kg/m2;
  • Invasive mechanical ventilation >90 days;
  • Currently on ECMO; Any electrical device (implanted or external) that may be prone to interaction with, or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators

Study Requirements

Randomized, controlled, open-label, multi-center adaptive clinical trial (RCT) with 1:1 randomization to Treatment with the Lungpacer Diaphragm Pacing Therapy System (plus Standard of Care) as compared to Control (Standard of Care). Lungpacer DPT consists of six (6) sets of ten (10) stimulations, twice daily for a total of 120 stimulations/day over a duration of up to 30 days from randomization or until study exit. The maximum number of stimulations that a subject could receive is expected to be 3600 delivered over the course of 30 days.