A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
(RESCUE 3 Trial)

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Lungpacer Medical Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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

See 1 more

Treatment Details

Interventions

Diaphragm Pacing Therapy (Device)
Lungpacer Diaphragm Pacing Therapy (Device)

Participant Groups

2Treatment groups

Active Control

Group I: TreatmentActive Control1 Intervention

Subject receives Lungpacer Catheter for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation.

Group II: ControlActive Control1 Intervention

Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation.