Clinical trial NCT03107949: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
Official title: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Induced Diaphragm Dysfunction
Keywords: Diaphragm atrophy
VIDD
weaning failure
SBT
Lead sponsor: Lungpacer Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2017-04-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Placement of the LIVE Catheter
timeFrame: 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.
measure: Capture of phrenic nerve
timeFrame: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first
measure: Diaphragm contraction noted upon stimulation of the phrenic nerve
timeFrame: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first.
measure: Removal of LIVE Catheter
timeFrame: Removal of LIVE Catheter will occur 2 days after extubation or on day 30 if subject has not been extubated.
Secondary outcomes:
Other outcomes:
measure: Evaluation of SAE's related to the use of the LIVE Catheter
timeFrame: From enrollment and insertion of the LIVE Catheter through LIVE Catheter removal or day 30 whichever comes first.
Locations:
city: Gainesville
country: United States
facility: University of Florida Health Science Center - Shands
state: Florida
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Vice Presdient of Clinical Affairs, Lungpacer Medical, Inc.
name: Linda Clark, RN, BSN
role: STUDY_DIRECTOR
References: