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Ventilator Induced Diaphragm DysfunctionRESCUE2NCT03096639

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

A study testing Diaphragmatic Pacing Therapy DPTS in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventilator Induced Diaphragm Dysfunction
What is being tested?
Diaphragmatic Pacing Therapy DPTS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
21 sitesin 2 countries
Study dates
14 Sep 2017to 30 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 16Show fewer
  • 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.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Germany14 sites

  • Uniklinik RWTH Aachen

    Aachen, 52074

  • Heart and Diabetes Center Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Charite Universitatsmedizin Berlin - Mitte campus

    Berlin, 10117

  • Universitatsklinikum Bonn

    Bonn, 53105

  • Universitatsklinik Dresden

    Dresden, 01307

  • Universitatsmedizin Gottingen, Georg-August-Universitat

    Göttingen, 37075

  • Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg

    Hamburg, 21075

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg

  • Med Uni-Heidelberg

    Heidelberg, 69126

  • Universitätsklinikum Jena

    Jena

  • Klinikum Nuernberg

    Nuremberg, 90419

  • Universitatsklinikum Regensburg

    Regensburg, 93053

  • Fachkrankenhaus Kloster Grafschaft

    Schmallenberg

  • Wissenschaftliches Institut Bethanien fur Pneumologie e.V.

    Solingen, 42699

Other trials in Germany

France7 sites

  • CHU Angers, Reanimation Medicale

    Angers, 49933

  • Hopital Louis-Mourier

    Colombes, 92700

  • CHU Montpellier

    Montpellier

  • Centre Hospitalier Universitaire de Nice (CHU Nice)

    Nice, 06001

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • Pitie Salpetriere Hospital

    Paris, 75651

  • Centre Hospitalier Universitaire CHU

    Strasbourg, 67000

Other trials in France

About this study

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.

Read the 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.

Being tested
Diaphragmatic Pacing Therapy DPTS
Keywords
Diaphragm atrophy, VIDD, Weaning failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragmatic Pacing Therapy DPTSDevice

    Also called DPTS, LIVE Catheter

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

Study groups in NCT03096639
Study groupRoleWhat they receive
Diaphragm Pacing Therapy DPTSActive comparatorDiaphragm 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.
Receives: Device: Diaphragmatic Pacing Therapy DPTS
Control GroupNo interventionStandard of care treatment of weaning failure, no intervention is involved in this control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Days on mechanical ventilation

    Days on mechanical ventilation from randomization to removal from MV associated with successful weaning or Day 30, whichever comes first

    Measured: from randomization to 30 days

  2. 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;

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

  3. Changes in MIP

    Change in MIP from randomization to last available measure; Change in MIP over time from randomization (baseline).

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

  4. Change in MIP

    Rate of MIP change per day from randomization (baseline) to last available measure;

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

  5. Changes in RSBI

    Change in RSBI from randomization (baseline) to last available measure; Change in RSBI over time from randomization (baseline);

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

  6. Change in RSBI

    Rate of RSBI change per day from randomization (baseline) to last available measure;

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

  7. Mortality

    30-day mortality

    Measured: on day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start14 Sep 2017
  3. Primary completion29 Dec 2019
  4. Study completion30 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization of treatment and control group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096639
Sponsor's protocol ID
P-200
Acronym
RESCUE2
Status last verified
Nov 2022
First submitted
15 Mar 2017
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study and it will be available through the clinical research organization (CRO).

Publications

  • 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.

    PubMed 30654837

  • 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.

    PubMed 35108175

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragmatic Pacing Therapy DPTS in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control. (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096639, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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