Clinical trial NCT03096639: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
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
Lead sponsor: Lungpacer Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2017-03-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization of treatment and control group
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.

Detailed description: Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventricular induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as short as 18 hours. The Lungpacer Diaphragm Pacing Therapy System (DPTS) is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the Lungpacer Control Unit 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. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. The randomized clinical trial will investigate the safety, effectiveness and performance of the Lungpacer DPTS. By stimulating the diaphragm through daily therapy sessions, with the intention of exercising and rehabilitating the diaphragm muscle so the patient may be able to be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for greater than or equal to 96 hours (4days), have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest spontaneous breathing trial. Patients must have resolution of the initial indication for placement on mechanical ventilation before entering the trial.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* have been mechanically ventilated for \> or = to 96 hours (4 days), and
* have satisfied the Readiness-to-Wean criteria and
* have failed at least two VLTs, one of which is the study specific VLT.

Exclusion Criteria:

* currently on extracorporeal membrane oxygenation (ECMO);
* weaning failure due to hypervolemia;
* medical history or known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein;
* currently being treated with neuromuscular blockade;
* clinically overt congestive heart failure that is preventing weaning;
* pre-existing neuromuscular diseases that could affect the respiratory muscles;
* pre-existing severe chronic pulmonary fibrosis;
* 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;
* prior bacteremia reported within the last 48 hours;
* current hemodynamic instability, sepsis or septic shock;
* terminally ill with 6 months or less life expectancy or not committed to full care;
* known or suspected to be pregnant or lactating; and
* currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

Primary outcomes:
measure: Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.
timeFrame: Patients will be allowed to stay in the study for up to 30 (+2 days of follow up for adverse events) days if not removed from mechanical ventilation sooner
Secondary outcomes:
measure: Days on mechanical ventilation
timeFrame: from randomization to 30 days
measure: Changes in diaphragmatic thickening fraction on diaphragm ultrasound
timeFrame: to successful weaning or on day 30 which ever comes first.
measure: Changes in MIP
timeFrame: to successful weaning, or on day 30, whichever comes first.
measure: Change in MIP
timeFrame: to successful weaning, or on day 30 whichever comes first.
measure: Changes in RSBI
timeFrame: to successful weaning, or on day 30, whichever comes first
measure: Change in RSBI
timeFrame: to successful weaning, or on day 30, whichever comes first
measure: Mortality
timeFrame: on day 30
Other outcomes:
measure: Weaning from and re-installation of Mechanical Ventilation in both groups
timeFrame: from randomization to 30 days
measure: Tracheostomy
timeFrame: from randomization to 30 days
measure: Ventilator settings
timeFrame: from randomization to 30 days
measure: Ventilator settings
timeFrame: from randomization to 30 days
measure: Ventilator settings
timeFrame: from randomization to 30 days
measure: Ventilator settings
timeFrame: from randomization to 30 days
measure: Number of ICU admissions and discharges through D30 for both groups
timeFrame: from randomization to 30 days
measure: Number of hospital admissions and discharges through D30 for both groups
timeFrame: from randomization to 30 days
Locations:
city: Angers
country: France
facility: CHU Angers, Reanimation Medicale
city: Colombes
country: France
facility: Hopital Louis-Mourier
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice (CHU Nice)
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Paris
country: France
facility: Pitie Salpetriere Hospital
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire CHU
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center Bad Oeynhausen
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin - Mitte campus
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Dresden
country: Germany
facility: Universitatsklinik Dresden
city: Gottingen
country: Germany
facility: Universitatsmedizin Gottingen, Georg-August-Universitat
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
city: Heidelberg
country: Germany
facility: Med Uni-Heidelberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg
city: Regensburg
country: Germany
facility: Universitatsklinikum Regensburg
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster Grafschaft
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien fur Pneumologie e.V.
Study officials:
affiliation: Vice President of Clinical Affairs, Lungpacer Medical, Inc.
name: Linda H Clark, BSN
role: STUDY_DIRECTOR
References:
citation: Evans D, Shure D, Clark L, Criner GJ, Dres M, de Abreu MG, Laghi F, McDonagh D, Petrof B, Nelson T, Similowski T. Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial. Trials. 2019 Jan 17;20(1):60. doi: 10.1186/s13063-018-3171-9.
citation: Dres M, de Abreu MG, Merdji H, Muller-Redetzky H, Dellweg D, Randerath WJ, Mortaza S, Jung B, Bruells C, Moerer O, Scharffenberg M, Jaber S, Besset S, Bitter T, Geise A, Heine A, Malfertheiner MV, Kortgen A, Benzaquen J, Nelson T, Uhrig A, Moenig O, Meziani F, Demoule A, Similowski T; RESCUE-2 Study Group Investigators. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients. Am J Respir Crit Care Med. 2022 May 15;205(10):1169-1178. doi: 10.1164/rccm.202107-1709OC.