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

Study Overview
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Brief Summary
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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.

Detailed Description
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Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as little as 18 hours. The DPTS is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the lungpacer Control Unit (LCU) 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 in order to stimulate the nerves to recruit the diaphragm. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. This early feasibility trial will investigate the safety and feasibility of the DPTS as a therapy to recondition and strengthen the diaphragm by stimulating the diaphragm through daily sessions so the patient may be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for > or = to 7 days, have failed two or more SBTs, and were not hypervolemic during the latest SBT. Patients must have resolution of the initial indication for placement on MV before entering the trial.

Official Title
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Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

Conditions
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Ventilator Induced Diaphragm Dysfunction

Intervention / Treatment
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* Device: Lungpacer DPTS (Diaphragm Pacing Therapy System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: LIVE Catheter is temporarily insertied into the left subclavian vein and connected to the LCU for DPTS to be delivered daily. The DPTS includes the LIVE Catheter, LCU and intermediate cable.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lungpacer Diaphragm Pacing Therapy (DPTS)<br>The LIVE Catheter will be temporarily inserted (LIVE Catheter will be inserted into every patient enrolled and can stay in place for up to 30 days) into the left subclavian vein and connected to the Lungpacer Control Unit in order to perform diaphragm pacing to stimulate the phrenic nerves and activate the diaphragm 3 x a day on all patients until extubated/removed from mechanical ventilation or until day 30 whichever comes first. | Device: Lungpacer DPTS (Diaphragm Pacing Therapy System)<br>* Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.<br>* Other names: LIVE Catheter; RESCUE 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Placement of the LIVE Catheter | Successful placement of the LIVE Catheter via the Left Subclavian vein at the initiation of study will be assessed by placement confirmation via Chest Xray | You will undergo an evaluation immediately following the LIVE Catheter insertion procedure to confirm that the LIVE Catheter has been successfully placed in the correct position in your vein. | 
| Capture of phrenic nerve | Successful capture and stimulation of at least one phrenic nerve as assessed by the change in the ventilator waveform and or diaphragm contraction. | Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first | 
| Diaphragm contraction noted upon stimulation of the phrenic nerve | Demonstration of the ability to contract the diaphragm via phrenic nerve stimulation will be evaluated by palpation of the diaphragm or visualization of the ventilator waveform change. | Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first. | 
| Removal of LIVE Catheter | Successful removal of the LIVE Catheter two days after date of extubation but before the end of the study on day 32 | Removal of LIVE Catheter will occur 2 days after extubation or on day 30 if subject has not been extubated. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragm atrophy, VIDD, weaning failure, SBT