Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (NCT03096639) | Clinical Trial Compass
CompletedNot Applicable
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
France110 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 range18 Years
SexALL
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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.
What they're measuring
1
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