Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE2)
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|ClinicalTrials.gov Identifier: NCT03096639|
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventilator Induced Diaphragm Dysfunction||Device: Diaphragmatic Pacing Therapy DPTS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomization of treatment and control group|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The ultrasound core lab reviewers will be blinded to study allocation groups|
|Official Title:||Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing|
|Actual Study Start Date :||September 14, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
Active Comparator: Diaphragm Pacing Therapy DPTS
Diaphragm 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.
Device: Diaphragmatic Pacing Therapy DPTS
Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.
No Intervention: Control Group
Standard of care treatment of weaning failure, no intervention is involved in this control group.
- Time to Successful Extubation with No Reintubation within 48 hours [ Time Frame: Patients will be allowed to stay in the study for up to 30 days if not extubated sooner. ]Removal from mechanical ventilation for greater than or equal to 48 hours during the study duration of 30 days
- Time to reintubation if applicable [ Time Frame: from randomization to 30 days ]time placed back on mechanical ventilation
- Changes in diaphragmatic thickness on diaphragm ultrasound [ Time Frame: to successful weaning or on day 30 which ever comes first. ]Evaluate difference in changes in diaphragmatic thickness between study allocation groups from randomization to successful weaning or on day 30 whichever comes first;
- Changes in diaphragmatic thickening fraction on diaphragm ultrasound [ Time Frame: to successful weaning or on day 30 which ever comes first. ]Evaluate difference in changes in diaphragmatic thickening fraction between study allocation groups from randomization to successful weaning or on day 30 whichever comes first;
- Changes in MIP [ Time Frame: Successful weaning, or on day 30, whichever comes first. ]Evaluate difference in changes in MIP between study allocations from randomization successful weaning, or on day 30 post procedure, whichever comes first.
- RSBI [ Time Frame: Successful weaning, or on day 30 whichever comes first. ]Daily rapid shallow breathing index (RSBI) measurements collected during the SBTs, or on spontaneous breathing mode if unable to perform an SBT.
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): NCT03096639
|Contact: Linda H Clark, BSNemail@example.com|
|Contact: Alfred Ricerfirstname.lastname@example.org|
|Study Director:||Linda H Clark, BSN||Vice President of Clinical Affairs, Lungpacer Medical, Inc.|