NCT03096639: RESCUE2

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

Completed NA Last updated 16 November 2022

What this trial tests

NA trial testing Diaphragmatic Pacing Therapy DPTS in Ventilator Induced Diaphragm Dysfunction in 110 participants. Completed in 30 January 2020.

Timeline

14 September 2017

Primary endpoint
29 December 2019

30 January 2020

Quick facts

Lead sponsor	Lungpacer Medical Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	110
Start date	14 September 2017
Primary completion	29 December 2019
Estimated completion	30 January 2020
Sites	21 locations across France, Germany

Drugs / interventions tested

• Diaphragmatic Pacing Therapy DPTS

Conditions studied

• Ventilator Induced Diaphragm Dysfunction — all drugs for Ventilator Induced Diaphragm Dysfunction →

Sponsor

Lungpacer Medical Inc. — full company profile →

Who can join

18 and older, any sex, with Ventilator Induced Diaphragm Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort.
   Goligher EC, Jonkman AH, Dianti J, Vaporidi K, et al · · 2020 · cited 118× · PMID 33140181 · DOI 10.1007/s00134-020-06288-9
2. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients.
   Dres M, de Abreu MG, Merdji H, Müller-Redetzky H, et al · · 2022 · cited 54× · PMID 35108175 · DOI 10.1164/rccm.202107-1709oc
3. Ventilator-induced diaphragm dysfunction: translational mechanisms lead to therapeutical alternatives in the critically ill.
   Peñuelas O, Keough E, López-Rodríguez L, Carriedo D, et al · · 2019 · cited 39× · PMID 31346802 · DOI 10.1186/s40635-019-0259-9
4. Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.
   Evans D, Shure D, Clark L, Criner GJ, et al · · 2019 · cited 21× · PMID 30654837 · DOI 10.1186/s13063-018-3171-9
5. Ventilator-induced diaphragm dysfunction in critical illness.
   Liu YY, Li LF. · · 2018 · cited 19× · PMID 30453774 · DOI 10.1177/1535370218811950
6. Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis.
   Jonkman AH, Frenzel T, McCaughey EJ, McLachlan AJ, et al · · 2020 · cited 10× · PMID 33126902 · DOI 10.1186/s13054-020-03352-0
7. The COPD Pipeline XXXV.
   Gross N. · · 2017 · PMID 28848935 · DOI 10.15326/jcopdf.4.3.2017.0154