A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation (RESCUE3)
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|ClinicalTrials.gov Identifier: NCT03783884|
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : October 8, 2020
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Ventilator Induced Diaphragm Dysfunction||Device: Diaphragm Pacing Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomization of treatment and control group|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||June 14, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Active Comparator: Treatment
Subject receives Lungpacer LIVE Catheter insertion 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.
Device: Diaphragm Pacing Therapy
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
Other Name: DPTS
No Intervention: Control
Subject does not receive Lungpacer LIVE Catheter or DPTS. Subject receives only Standard of care for weaning from mechanical ventilation.
- Successful wean [ 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.
- Maximal Inspiratory Pressure mean change [ Time Frame: 30 days ]The MIP mean change from baseline will be statistically significantly greater for subjects randomized to Lungpacer DPTS compared to subjects randomized to Control.
- Change in Rapid Shallow Breathing Index (RSBI) [ Time Frame: 30 days ]Change in RSBI over time from randomization (baseline)
- 30 day mortality [ Time Frame: 30 days ]To compare Treatment (Lungpacer DPTS) subjects to Control subjects for Day 30 mortality.
- Rate of RSBI change [ Time Frame: 30 days ]Rate of RSBI change per day from randomization (baseline) to last available measure
- Rate of MIP change [ Time Frame: 30 days ]Rate of MIP change per day from randomization (baseline) to last available measure;
- Change in MIP [ Time Frame: 30 days ]Change in MIP over time from randomization (baseline)
- Days on MV [ Time Frame: successful weaning or day 30 ]Days on mechanical ventilation from Day 1 to removal from MV associated with successful weaning or Day 30, whichever comes first.
- Adverse event assessment [ Time Frame: 30 days ]Adverse events for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783884
|Contact: Sara Hill||(484) firstname.lastname@example.org|
|Contact: Linda Clark, RNemail@example.com|
|Study Director:||Linda Clark||Vice President of Clinical Affairs|