Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

NCT ID: NCT03096639

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2020-01-30

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.

Conditions

Ventilator Induced Diaphragm Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diaphragm Pacing Therapy DPTS

Diaphragm Pacing intervention will be conducted 2x a day using the Diaphragmatic Pacing Therapy System (DPTS). The DPTS includes the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) which is inserted temporarily into the left subclavian vein, the Lungpacer Control Unit (LCU external unit) and an intermediate cable that connects the LCU to the LIVE Catheter.

Group Type: ACTIVE_COMPARATOR

Diaphragmatic Pacing Therapy DPTS

Intervention Type: DEVICE

Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.

Control Group

Standard of care treatment of weaning failure, no intervention is involved in this control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diaphragmatic Pacing Therapy DPTS

Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.

Intervention Type: DEVICE

Other Intervention Names

DPTS; LIVE Catheter

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntactx

NETWORK

Sponsor Role: collaborator

Lungpacer Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda H Clark, BSN

Role: STUDY_DIRECTOR

Vice President of Clinical Affairs, Lungpacer Medical, Inc.

Locations

CHU Angers, Reanimation Medicale

Angers, , France

Hopital Louis-Mourier

Colombes, , France

CHU Montpellier

Montpellier, , France

Centre Hospitalier Universitaire de Nice (CHU Nice)

Nice, , France

Hopital Europeen Georges-Pompidou

Paris, , France

Pitie Salpetriere Hospital

Paris, , France

Centre Hospitalier Universitaire CHU

Strasbourg, , France

Uniklinik RWTH Aachen

Aachen, , Germany

Heart and Diabetes Center Bad Oeynhausen

Bad Oeynhausen, , Germany

Charite Universitatsmedizin Berlin - Mitte campus

Berlin, , Germany

Universitatsklinikum Bonn

Bonn, , Germany

Universitatsklinik Dresden

Dresden, , Germany

Universitatsmedizin Gottingen, Georg-August-Universitat

Göttingen, , Germany

Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg

Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, , Germany

Med Uni-Heidelberg

Heidelberg, , Germany

Universitätsklinikum Jena

Jena, , Germany

Klinikum Nuernberg

Nuremberg, , Germany

Universitatsklinikum Regensburg

Regensburg, , Germany

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, , Germany

Wissenschaftliches Institut Bethanien fur Pneumologie e.V.

Solingen, , Germany

Countries

France; Germany

References

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.

Reference Type: BACKGROUND

PMID: 30654837 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35108175 (View on PubMed)

Other Identifiers

P-200

Identifier Type: -

Identifier Source: org_study_id