MedTrace Logo

A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation

NCT03783884 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Ventilator Induced Diaphragm Dysfunction

Interventions

DEVICE

Lungpacer Diaphragm Pacing Therapy

Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Sponsors & Collaborators

  • Lungpacer Medical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2022-12-28
Completion
2023-01-27
FDA Device
Yes

Countries

  • United States
  • France
  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783884 on ClinicalTrials.gov