Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)

Completed · Not applicable

Conditions studied: Ventilator Induced Diaphragm Dysfunction

In brief

An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for \> or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.

Key facts

Study ID

NCT03107949

Run by

Lungpacer Medical Inc.

People needed

9

Starts

2017-06-20

Expected to finish

2018-02-18

Last updated by the study team

2021-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• have been mechanically ventilated for > or = 7 days and have not met criteria for successful weaning during this period; and
• have failed at least two SBTs, one of which is the study specific SBT. (Self-extubation with subsequent reintubation within 48 hours is considered a failed SBT).

You may not qualify if…

• currently on extracorporeal membrane oxygenation (ECMO);
• weaning failure due to hypervolemia;
• known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein;
• history of congenital heart disease;
• clinically overt congestive heart failure;
• pre-existing neuromuscular diseases that could affect the respiratory muscles;
• 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;
• bacteremia (blood cultures must be negative for 48 hours);
• current haemodynamic instability, shock or severe sepsis;
• terminally ill with 6 months or less life expectancy or not committed to full care;
• known or suspected to be pregnant or lactating; and
• actively participating in another clinical study

Where it is running

• University of Florida Health Science Center - Shands — Gainesville, Florida, United States
• New York University Medical Center — New York, New York, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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