Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

NCT03096639 | Completed DMC FDA Device

• 1 other identifier: P-200
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 21

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.

Conditions

Ventilator Induced Diaphragm Dysfunction

Keywords

Diaphragm atrophy; VIDD; Weaning failure

Outcome Measures

Primary Outcomes (1)

• Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.

  "Successfully weaned" is defined as passing the protocol-specific Ventilator Liberation Trial (VLT), or removed from MV, and not reintubated (subjects with an oral or nasal, endotracheal tube) or returned to MV (subjects with a tracheostomy) within 48 hours

  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 (7)

• Days on mechanical ventilation

  from randomization to 30 days

• Changes in diaphragmatic thickening fraction on diaphragm ultrasound

  to successful weaning or on day 30 which ever comes first.

• Changes in MIP

  to successful weaning, or on day 30, whichever comes first.

• Change in MIP

  to successful weaning, or on day 30 whichever comes first.

• Changes in RSBI

  to successful weaning, or on day 30, whichever comes first

Other Outcomes (8)

• Weaning from and re-installation of Mechanical Ventilation in both groups

  from randomization to 30 days

• Tracheostomy

  from randomization to 30 days

• Ventilator settings

  from randomization to 30 days

Study Arms (2)

Diaphragm Pacing Therapy DPTS

ACTIVE COMPARATOR

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.

Device: Diaphragmatic Pacing Therapy DPTS

Control Group

NO INTERVENTION

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

Interventions

Diaphragmatic Pacing Therapy DPTS DEVICE

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

Also known as: DPTS, LIVE Catheter

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 = 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lungpacer Medical Inc.: lead
• Syntactx: collaborator

Study Sites (21)

CHU Angers, Reanimation Medicale

Angers, 49933, France

Location

Hopital Louis-Mourier

Colombes, 92700, France

Location

CHU Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire de Nice (CHU Nice)

Nice, 06001, France

Location

Hopital Europeen Georges-Pompidou

Paris, 75015, France

Location

Pitie Salpetriere Hospital

Paris, 75651, France

Location

Centre Hospitalier Universitaire CHU

Strasbourg, 67000, France

Location

Uniklinik RWTH Aachen

Aachen, 52074, Germany

Location

Heart and Diabetes Center Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Charite Universitatsmedizin Berlin - Mitte campus

Berlin, 10117, Germany

Location

Universitatsklinikum Bonn

Bonn, 53105, Germany

Location

Universitatsklinik Dresden

Dresden, 01307, Germany

Location

Universitatsmedizin Gottingen, Georg-August-Universitat

Göttingen, 37075, Germany

Location

Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg

Hamburg, 21075, Germany

Location

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, Germany

Location

Med Uni-Heidelberg

Heidelberg, 69126, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Klinikum Nuernberg

Nuremberg, 90419, Germany

Location

Universitatsklinikum Regensburg

Regensburg, 93053, Germany

Location

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, Germany

Location

Wissenschaftliches Institut Bethanien fur Pneumologie e.V.

Solingen, 42699, Germany

Location

Related Publications (2)

• 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.

  PMID: 30654837 BACKGROUND

• 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.

  PMID: 35108175 RESULT

Study Officials

• Linda H Clark, BSN

  Vice President of Clinical Affairs, Lungpacer Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ultrasound core lab reviewers will be blinded to study allocation groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization of treatment and control group

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 30, 2017
• Study Start: September 14, 2017
• Primary Completion: December 29, 2019
• Study Completion: January 30, 2020
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

DE (14); FR (7)