CompletedNot Applicable

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

France, Germany110 participantsStarted 2017-09-14

Plain-language summary

A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older * have been mechanically ventilated for \> or = to 96 hours (4 days), and * have satisfied the Readiness-to-Wean criteria and * have failed at least two VLTs, one of which is the study specific VLT. Exclusion Criteria: * currently on extracorporeal membrane oxygenation (ECMO); * weaning failure due to hypervolemia; * medical history or known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein; * currently being treated with neuromuscular blockade; * clinically overt congestive heart failure that is preventing weaning; * pre-existing neuromuscular diseases that could affect the respiratory muscles; * pre-existing severe chronic pulmonary fibrosis; * pleural effusions occupying greater than one third of the pleural space on either side; * BMI \> or = 40; * known or suspected phrenic nerve paralysis; * 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; * prior bacteremia reported within the last 48 hours; * current hemodynamic instability, sepsis or septic shock; * terminally ill with 6 months or less life expectancy or not committed to full care; * known or suspected to be pregnant or lactating; and * currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.

Timeframe: Patients will be allowed to stay in the study for up to 30 (+2 days of follow up for adverse events) days if not removed from mechanical ventilation sooner

Trial details

NCT IDNCT03096639

SponsorLungpacer Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-29

View on ClinicalTrials.gov More Ventilator Induced Diaphragm Dysfunction trials