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

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Induced Diaphragm Dysfunction
• Intervention / Treatment: Device: Lungpacer DPTS (Diaphragm Pacing Therapy System)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Health Science Center - Shands
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lungpacer Diaphragm Pacing Therapy (DPTS); 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); Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.; Other Names: LIVE Catheter; RESCUE 1

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Lungpacer Medical Inc.
• Collaborators: Syntactx
• Investigators: Study Director: Linda Clark, RN, BSN, Vice Presdient of Clinical Affairs, Lungpacer Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): February 18, 2018

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Diaphragm atrophy; VIDD; weaning failure; SBT
• Other Study ID Numbers: P-100; G170057 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study and it will be available through Syntactx.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes