Back to resultsRandomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Primary Purpose
Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NeuRx Diaphragm Pacing System (DPS)
Sponsored by
About this trial
This is an interventional treatment trial for Diaphragm Issues focused on measuring Mechanical Ventilators, Ventilators, Pulmonary, Failure to wean, Lung Injury, Ventilator-Induced, Tracheostomy, Diaphragm pacing
Eligibility Criteria
Inclusion Criteria:
- Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
- Signed written informed consent has been obtained prior to performing any study related procedure(s)
- Subject is at least 18 years of age
- Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)
Exclusion Criteria:
- Diaphragm malformation which makes electrode insertion impossible
- Presence of an implantable cardioverter-defibrillator
- Severe chronic obstructive pulmonary disease (COPD)
- Subject is pregnant or breastfeeding
- Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
- Terminal patients expected to die during their stay in the hospital
- Participation in other clinical studies that could interfere with the results in the ongoing study
Sites / Locations
- Marmara Univeristy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Tracheostomy, no DPS
Trachesotomy with immediate DPS stimulation and monitoring
Trachesotomy with DPS monitoring, stimulation on day 5
Arm Description
5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.
5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.
5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure.
Outcomes
Primary Outcome Measures
Device and procedure safety
Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
Monitoring
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Stimulation
Increase in magnitude of diaphragm burst activity with stimulation
Secondary Outcome Measures
Effects of diaphragm stimulation
Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457427
Brief Title
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Official Title
Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study not started
Study Start Date
December 2016 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synapse Biomedical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
Detailed Description
15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
Keywords
Mechanical Ventilators, Ventilators, Pulmonary, Failure to wean, Lung Injury, Ventilator-Induced, Tracheostomy, Diaphragm pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tracheostomy, no DPS
Arm Type
No Intervention
Arm Description
5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.
Arm Title
Trachesotomy with immediate DPS stimulation and monitoring
Arm Type
Experimental
Arm Description
5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.
Arm Title
Trachesotomy with DPS monitoring, stimulation on day 5
Arm Type
Active Comparator
Arm Description
5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure.
Intervention Type
Device
Intervention Name(s)
NeuRx Diaphragm Pacing System (DPS)
Intervention Description
4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.
Primary Outcome Measure Information:
Title
Device and procedure safety
Description
Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
Time Frame
Through study completion, an average of 6 years
Title
Monitoring
Description
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Time Frame
Through study completion, an average of 6 years
Title
Stimulation
Description
Increase in magnitude of diaphragm burst activity with stimulation
Time Frame
Through study completion, an average of 6 years
Secondary Outcome Measure Information:
Title
Effects of diaphragm stimulation
Description
Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay
Time Frame
Through study completion, an average of 6 years
Other Pre-specified Outcome Measures:
Title
Electrode removal
Description
(3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first
Time Frame
Through study completion, an average of 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
Signed written informed consent has been obtained prior to performing any study related procedure(s)
Subject is at least 18 years of age
Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)
Exclusion Criteria:
Diaphragm malformation which makes electrode insertion impossible
Presence of an implantable cardioverter-defibrillator
Severe chronic obstructive pulmonary disease (COPD)
Subject is pregnant or breastfeeding
Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
Terminal patients expected to die during their stay in the hospital
Participation in other clinical studies that could interfere with the results in the ongoing study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tunç Laçin, MD
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara Univeristy
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Links:
URL
http://www.synapsebiomedical.com/
Description
Click here for more information about the Sponsor.
Learn more about this trial
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
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