Ventilator Induced Diaphragm DysfunctionRESCUE 3NCT03783884
A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
A study testing Lungpacer Diaphragm Pacing Therapy in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc. at 33 sites in 3 countries.
Trial summary
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. 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?
- Lungpacer Diaphragm Pacing Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 33 sitesin 3 countries
- Study dates
- 14 Jun 2019to 27 Jan 2023
- 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
- Are 18 years or older, and,
- Have been mechanically ventilated for ≥96 hours (4 days), and,
- Have satisfied the Readiness-to-Wean criteria, and,
- Have failed at least 2 weaning attempts (that were conducted at least 48 hours after initiation of MV, and, that were conducted on different calendar days, and, at least one of which was the protocol-specific Ventilator Liberation Trial).
Who cannot join
- MIP (absolute value) >50 cm H2O;
- Invasive mechanical ventilation >90 days;
- Currently on ECMO;
- Weaning failure due to hypervolemia;
- Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
- Clinically overt congestive heart failure that is preventing weaning;
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- Currently being treated with neuromuscular blockade;
- Pre-existing neurological, neuromuscular or muscular disorder 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 >45 kg/m2;
- 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;
- Current hemodynamic instability, sepsis or septic shock;
- Prior bacteremia reported within the last 48 hours;
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care;
- Known or suspected to be pregnant or lactating;
- Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
United States22 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
U of Illinois at Chicago
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Prisma Health Baptist Hospital
Columbia, South Carolina, 29203
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern, Zale Lipshy Hospital
Dallas, Texas, 75390
Englewood Hospital Medical Center
Englewood, New Jersey, 07631
University of Florida, Shands
Gainesville, Florida, 32610
Edward Hines VA Hospital
Hines, Illinois, 60141
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
University of Louisville
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, Nebraska, 68124
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Utah
Salt Lake City, Utah, 84132
Stanford University Medical Center
Stanford, California, 94305
Kent County Memorial Hospital
Warwick, Rhode Island, 02886
Germany7 sites
Berlin Charite Mitte
Berlin, 10117
KEM Essen
Essen, 45276
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
SLK Löwenstein
Löwenstein, 74245
Nürnberg Klinikum Nord
Nuremberg, 90419
FKKG Schmallenberg
Schmallenberg, 57392
Solingen Krankenhaus Bethanien
Solingen, 42699
France4 sites
CHU Angers
Angers, 49933
CHU Montpellier
Montpellier, 34295
Hôpital La Pitié-Salpêtrière
Paris, 75651
CHU Strasbourg
Strasbourg, 67091
About this study
Official title: A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and have failed two weaning attempts.
The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
Read the detailed description
The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (>7 days). The intended patient population includes approximately one-third of all patients on mechanical ventilation. Under standard of care, approximately 50% of these patients will recover from mechanical ventilation (Jung, 2016). Standard of care involves daily weaning attempts, known as Spontaneous Breathing Trials (SBTs) or Ventilator Liberation Trials (VLTs) that are intended to encourage diaphragm use and strengthening over time.Therefore, Lungpacer DPT efficacy evaluation must be compared to standard of care in a Control group. Lack of recovery from mechanical ventilation may be due to the inability of a patient to participate in VLTs or weaning attempts, due to extensive diaphragm weakness or sedation, the inability of VLTs to induce sufficient diaphragm strengthening, or co-morbidities that prevent recovery.
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Being tested
- Lungpacer Diaphragm Pacing Therapy
- Keywords
- VIDD, Diaphragm Atrophy, Weaning Failure, VLT, SBT, VILI, Phrenic Nerve Stimulation, Maximal Inspiratory Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lungpacer Diaphragm Pacing TherapyDevice
Also called Lungpacer DPTS, AeroPace System
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Subject receives Lungpacer Catheter for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation. Receives: Device: Lungpacer Diaphragm Pacing Therapy |
| Control | No intervention | Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Weaning
The proportion of subjects who are successfully weaned will be statistically significantly greater for subjects randomized to Treatment (Lungpacer DPTS) compared to subjects randomized to Control.
Measured: 30 days
Adverse Event Profile
Characterize the adverse event profile to support an observed consistent risk profile for subjects randomized to Treatment compared to subjects randomized to Control.
Measured: 30 days
Secondary outcomes (4)
Days on MV
The average days on mechanical ventilation from Day 1 to removal from MV associated with successful weaning or Day 30, whichever comes first, will be statistically significantly smaller for subjects randomized to Treatment as compared to subjects randomized to Control.
Measured: Successful weaning or Day 30
Maximal Inspiratory Pressure (MIP) Change
The mean improvement in inspiratory muscle strength as shown by the change in Maximal Inspiratory Pressure (MIP) from randomization to last available measure in subjects randomized to Treatment is superior to that in subjects randomized to Control.
Measured: 30 days
Rapid Shallow Breathing Index (RSBI) Change
To determine change in Rapid Shallow Breathing Index (RSBI) from randomization to last available measure in subjects randomized to Treatment as compared to Control.
Measured: 30 days
Mortality
To compare Treatment (Lungpacer DPTS) subjects to Control subjects for mortality through Day 30.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start14 Jun 2019
- Primary completion28 Dec 2022
- Study completion27 Jan 2023
Why it stopped: Low enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Induced Diaphragm DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lungpacer Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783884
- Sponsor's protocol ID
- P-300
- Acronym
- RESCUE 3
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2018
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT03783884
- Acronym / sponsor ID
- RESCUE 3 / P-300
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Keywords
- VIDD, Diaphragm Atrophy, Weaning Failure, VLT, SBT, VILI, Phrenic Nerve Stimulation, Maximal Inspiratory Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rate.
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Lungpacer Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and have failed two weaning attempts.
The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
Detailed description
The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (>7 days). The intended patient population includes approximately one-third of all patients on mechanical ventilation. Under standard of care, approximately 50% of these patients will recover from mechanical ventilation (Jung, 2016). Standard of care involves daily weaning attempts, known as Spontaneous Breathing Trials (SBTs) or Ventilator Liberation Trials (VLTs) that are intended to encourage diaphragm use and strengthening over time.Therefore, Lungpacer DPT efficacy evaluation must be compared to standard of care in a Control group. Lack of recovery from mechanical ventilation may be due to the inability of a patient to participate in VLTs or weaning attempts, due to extensive diaphragm weakness or sedation, the inability of VLTs to induce sufficient diaphragm strengthening, or co-morbidities that prevent recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization of treatment and control group
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Lungpacer Diaphragm Pacing TherapySubject receives Lungpacer Catheter for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation. |
| Control | No intervention | –Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are 18 years or older, and,
- Have been mechanically ventilated for ≥96 hours (4 days), and,
- Have satisfied the Readiness-to-Wean criteria, and,
- Have failed at least 2 weaning attempts (that were conducted at least 48 hours after initiation of MV, and, that were conducted on different calendar days, and, at least one of which was the protocol-specific Ventilator Liberation Trial).
Key exclusion criteria (18 listed)
- MIP (absolute value) >50 cm H2O;
- Invasive mechanical ventilation >90 days;
- Currently on ECMO;
- Weaning failure due to hypervolemia;
- Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lungpacer Diaphragm Pacing TherapyAlso: Lungpacer DPTS, AeroPace SystemTransvenous phrenic nerve stimulation to induce diaphragm contraction. | Device | Treatment |
Primary outcome
Successful Weaning
Time frame: 30 days
The proportion of subjects who are successfully weaned will be statistically significantly greater for subjects randomized to Treatment (Lungpacer DPTS) compared to subjects randomized to Control.
Adverse Event Profile
Time frame: 30 days
Characterize the adverse event profile to support an observed consistent risk profile for subjects randomized to Treatment compared to subjects randomized to Control.
4 secondary outcomes
Days on MV
Time frame: Successful weaning or Day 30
Maximal Inspiratory Pressure (MIP) Change
Time frame: 30 days
Rapid Shallow Breathing Index (RSBI) Change
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Low enrollment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study.
Related trials for Ventilator Induced Diaphragm Dysfunction
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Ventilator-induced Diaphragm Dysfunction, VIDD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lungpacer Diaphragm Pacing Therapy in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc. at 33 sites in 3 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 18 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: stopped early, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, 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 was stopped early (reason given: Low enrollment rate.). Results are not available in the source record.
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?
Successful Weaning (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.