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

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ventilator Induced Diaphragm Dysfunction Device: Diaphragmatic Pacing Therapy DPTS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Official Title: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : December 29, 2019
Actual Study Completion Date : January 30, 2020
Arms and Interventions
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Arm Intervention/treatment
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.
Other Names:
  • DPTS
  • LIVE Catheter
No Intervention: Control Group
Standard of care treatment of weaning failure, no intervention is involved in this control group.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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;

  3. 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).

  4. 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;

  5. 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);

  6. 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;

  7. Mortality [ Time Frame: on day 30 ]
    30-day mortality


Other Outcome Measures:
  1. 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

  2. Tracheostomy [ Time Frame: from randomization to 30 days ]
    Proportion of subjects tracheotomized from randomization to study exit

  3. Ventilator settings [ Time Frame: from randomization to 30 days ]
    Pressure Support daily, to last available measure

  4. Ventilator settings [ Time Frame: from randomization to 30 days ]
    PEEP daily, to last available measure

  5. Ventilator settings [ Time Frame: from randomization to 30 days ]
    Ventilation Mode daily, to last available measure

  6. Ventilator settings [ Time Frame: from randomization to 30 days ]
    Tidal Volume daily, to last available measure

  7. 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

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Lungpacer Medical Inc.
Syntactx
Investigators
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Study Director: Linda H Clark, BSN Vice President of Clinical Affairs, Lungpacer Medical, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lungpacer Medical Inc.
ClinicalTrials.gov Identifier: NCT03096639    
Other Study ID Numbers: P-200
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
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).

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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
Keywords provided by Lungpacer Medical Inc.:
Diaphragm atrophy
VIDD
Weaning failure