Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

Ventilator Induced Diaphragm Dysfunction Clinical Trial

— RESCUE2  

Official title:

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096639
• Other study ID #: P-200
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2022
• Source: Lungpacer Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 30, 2020
• Est. primary completion date: December 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ventilator Induced Diaphragm Dysfunction

Intervention

Device:
• Diaphragmatic Pacing Therapy DPTS
Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.

Locations

Country	Name	City	State
France	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
Germany	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	Gottingen
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	Nuernberg
Germany	Universitatsklinikum Regensburg	Regensburg
Germany	Fachkrankenhaus Kloster Grafschaft	Schmallenberg
Germany	Wissenschaftliches Institut Bethanien fur Pneumologie e.V.	Solingen

Sponsors (2)

Lead Sponsor	Collaborator
Lungpacer Medical Inc.	Syntactx

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (2)

Dres M, de Abreu MG, Merdji H, Müller-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, Mezia — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weaning from and re-installation of Mechanical Ventilation in both groups	Cessations and re-instatements of mechanical ventilation to Day 30 or Study Exit	from randomization to 30 days
Other	Tracheostomy	Proportion of subjects tracheotomized from randomization to study exit	from randomization to 30 days
Other	Ventilator settings	Pressure Support daily, to last available measure	from randomization to 30 days
Other	Ventilator settings	PEEP daily, to last available measure	from randomization to 30 days
Other	Ventilator settings	Ventilation Mode daily, to last available measure	from randomization to 30 days
Other	Ventilator settings	Tidal Volume daily, to last available measure	from randomization to 30 days
Other	Number of ICU admissions and discharges through D30 for both groups	ICU admissions and discharges to day 30	from randomization to 30 days
Other	Number of hospital admissions and discharges through D30 for both groups	Hospital admissions and discharges to day 30.	from randomization to 30 days
Primary	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	Days on mechanical ventilation	Days on mechanical ventilation from randomization to removal from MV associated with successful weaning or Day 30, whichever comes first	from randomization to 30 days
Secondary	Changes in diaphragmatic thickening fraction on diaphragm ultrasound	Evaluate difference in changes in diaphragmatic thickening fraction between study allocation groups from randomization to successful weaning or on day 30 whichever comes first;	to successful weaning or on day 30 which ever comes first.
Secondary	Changes in MIP	Change in MIP from randomization to last available measure; Change in MIP over time from randomization (baseline).	to successful weaning, or on day 30, whichever comes first.
Secondary	Change in MIP	Rate of MIP change per day from randomization (baseline) to last available measure;	to successful weaning, or on day 30 whichever comes first.
Secondary	Changes in RSBI	Change in RSBI from randomization (baseline) to last available measure; Change in RSBI over time from randomization (baseline);	to successful weaning, or on day 30, whichever comes first
Secondary	Change in RSBI	Rate of RSBI change per day from randomization (baseline) to last available measure;	to successful weaning, or on day 30, whichever comes first
Secondary	Mortality	30-day mortality	on day 30