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

NCT03107949 | Completed DMC FDA Device

• 2 other identifiers: P-100G170057
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ventilator Induced Diaphragm Dysfunction

Keywords

Diaphragm atrophy; VIDD; weaning failure; SBT

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Evaluation of SAE's related to the use of the LIVE Catheter

  From enrollment and insertion of the LIVE Catheter through LIVE Catheter removal or day 30 whichever comes first.

Study Arms (1)

Lungpacer Diaphragm Pacing Therapy (DPTS)

EXPERIMENTAL

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)

Interventions

Lungpacer DPTS (Diaphragm Pacing Therapy System) DEVICE

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

Also known as: LIVE Catheter; RESCUE 1

Lungpacer Diaphragm Pacing Therapy (DPTS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Lungpacer Medical Inc.: lead
• Syntactx: collaborator

Study Sites (4)

University of Florida Health Science Center - Shands

Gainesville, Florida, 32610, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Study Officials

• Linda Clark, RN, BSN

  Vice Presdient of Clinical Affairs, Lungpacer Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 11, 2017
• Study Start: June 20, 2017
• Primary Completion: January 30, 2018
• Study Completion: February 18, 2018
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (4)