Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Sponsor
- Lungpacer Medical Inc.
- Enrollment
- 110
- Locations
- 21
- Primary Endpoint
- Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventricular induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as short as 18 hours. The Lungpacer Diaphragm Pacing Therapy System (DPTS) is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the Lungpacer Control Unit system. The LIVE Catheter is a proprietary central venous catheter that incorporates pacing electrodes in strategic areas that align with the left and right phrenic nerves. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. The randomized clinical trial will investigate the safety, effectiveness and performance of the Lungpacer DPTS. By stimulating the diaphragm through daily therapy sessions, with the intention of exercising and rehabilitating the diaphragm muscle so the patient may be able to be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for greater than or equal to 96 hours (4days), have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest spontaneous breathing trial. Patients must have resolution of the initial indication for placement on mechanical ventilation before entering the trial.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.
Time Frame: 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
"Successfully weaned" is defined as passing the protocol-specific Ventilator Liberation Trial (VLT), or removed from MV, and not reintubated (subjects with an oral or nasal, endotracheal tube) or returned to MV (subjects with a tracheostomy) within 48 hours
Secondary Outcomes
- Changes in MIP(to successful weaning, or on day 30, whichever comes first.)
- Days on mechanical ventilation(from randomization to 30 days)
- Mortality(on day 30)
- Changes in diaphragmatic thickening fraction on diaphragm ultrasound(to successful weaning or on day 30 which ever comes first.)
- Change in MIP(to successful weaning, or on day 30 whichever comes first.)
- Changes in RSBI(to successful weaning, or on day 30, whichever comes first)
- Change in RSBI(to successful weaning, or on day 30, whichever comes first)