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

Ventilator Induced Diaphragm Dysfunction Clinical Trial

— RESCUE1  

Official title:

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107949
• Other study ID #: P-100
• Secondary ID: G170057
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: February 18, 2018

Study information

• Verified date: May 2021
• Source: Lungpacer Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 18, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilator Induced Diaphragm Dysfunction

Intervention

Device:
• Lungpacer DPTS (Diaphragm Pacing Therapy System)
Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Lungpacer Medical Inc.	Syntactx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of SAE's related to the use of the LIVE Catheter	All SAE's related to the use of the LIVE Catheter will be evaluated to assess a reasonable safety profile associated with the LIVE Catheter insertion and removal procedure and the use of the DPTS in all study subjects.	From enrollment and insertion of the LIVE Catheter through LIVE Catheter removal or day 30 whichever comes first.
Primary	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.
Primary	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
Primary	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.
Primary	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.