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Phrenic Nerve Stimulation-Induced Lung ReAeration Trial

NCT04844892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-10-05

No results posted yet for this study

Summary

The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).

Conditions

  • Acute Respiratory Distress Syndrome
  • Ventilation Therapy; Complications

Interventions

DEVICE

Lungpacer PROTECT Diaphragm Pacing Therapy

PROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients.

Sponsors & Collaborators

  • Lungpacer Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Dres, MD · AP-HP Hôpital La Pitié-Salpêtrière

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2023-02-01
Completion
2023-02-13

Countries

  • France

Study Locations

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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 NCT04844892 on ClinicalTrials.gov