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Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03096639
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Lungpacer Medical Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 30, 2017
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE September 14, 2017
Actual Primary Completion Date December 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
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 ]
"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
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • Days on mechanical ventilation [ Time Frame: from randomization to 30 days ]
    Days on mechanical ventilation from randomization to removal from MV associated with successful weaning or 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: to successful weaning, or on day 30, whichever comes first. ]
    Change in MIP from randomization to last available measure; Change in MIP over time from randomization (baseline).
  • Change in MIP [ Time Frame: to successful weaning, or on day 30 whichever comes first. ]
    Rate of MIP change per day from randomization (baseline) to last available measure;
  • Changes in RSBI [ Time Frame: to successful weaning, or on day 30, whichever comes first ]
    Change in RSBI from randomization (baseline) to last available measure; Change in RSBI over time from randomization (baseline);
  • Change in RSBI [ Time Frame: to successful weaning, or on day 30, whichever comes first ]
    Rate of RSBI change per day from randomization (baseline) to last available measure;
  • Mortality [ Time Frame: on day 30 ]
    30-day mortality
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
Time to reintubation if applicable [ Time Frame: from randomization to 30 days ]
time placed back on mechanical ventilation
Current Other Pre-specified Outcome Measures
 (submitted: September 30, 2020)
  • Weaning from and re-installation of Mechanical Ventilation in both groups [ Time Frame: from randomization to 30 days ]
    Cessations and re-instatements of mechanical ventilation to Day 30 or Study Exit
  • Tracheostomy [ Time Frame: from randomization to 30 days ]
    Proportion of subjects tracheotomized from randomization to study exit
  • Ventilator settings [ Time Frame: from randomization to 30 days ]
    Pressure Support daily, to last available measure
  • Ventilator settings [ Time Frame: from randomization to 30 days ]
    PEEP daily, to last available measure
  • Ventilator settings [ Time Frame: from randomization to 30 days ]
    Ventilation Mode daily, to last available measure
  • Ventilator settings [ Time Frame: from randomization to 30 days ]
    Tidal Volume daily, to last available measure
  • Number of ICU admissions and discharges through D30 for both groups [ Time Frame: from randomization to 30 days ]
    ICU admissions and discharges to day 30
  • Number of hospital admissions and discharges through D30 for both groups [ Time Frame: from randomization to 30 days ]
    Hospital admissions and discharges to day 30.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
Official Title  ICMJE Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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
Primary Purpose: Treatment
Condition  ICMJE Ventilator Induced Diaphragm Dysfunction
Intervention  ICMJE Device: Diaphragmatic Pacing Therapy DPTS
Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.
Other Names:
  • DPTS
  • LIVE Catheter
Study Arms  ICMJE
  • 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.
    Intervention: Device: Diaphragmatic Pacing Therapy DPTS
  • No Intervention: Control Group
    Standard of care treatment of weaning failure, no intervention is involved in this control group.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2017)
88
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date December 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03096639
Other Study ID Numbers  ICMJE P-200
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: 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).
Current Responsible Party Lungpacer Medical Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lungpacer Medical Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Syntactx
Investigators  ICMJE
Study Director: Linda H Clark, BSN Vice President of Clinical Affairs, Lungpacer Medical, Inc.
PRS Account Lungpacer Medical Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP