A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From … (NCT03783884) | Clinical Trial Compass
TerminatedNot Applicable
A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
Stopped: Low enrollment rate.
United States223 participantsStarted 2019-06-14
Plain-language summary
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and have failed two weaning attempts.
The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Are 18 years or older, and,
✓. 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 (that were conducted at least 48 hours after initiation of MV, and, that were conducted on different calendar days, and, at least one of which was the protocol-specific Ventilator Liberation Trial).
Exclusion criteria
✕. MIP (absolute value) \>50 cm H2O;
✕. Invasive mechanical ventilation \>90 days;
✕. Currently on ECMO;
✕. Weaning failure due to hypervolemia;
✕. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
✕. Clinically overt congestive heart failure that is preventing weaning;