Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

June 30, 2020 updated by: Synapse Biomedical

Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Tracheostomy, no DPS
5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.
Experimental: Trachesotomy with immediate DPS stimulation and monitoring
5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.
Device: NeuRx Diaphragm Pacing System (DPS)
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.
Active Comparator: Trachesotomy with DPS monitoring, stimulation on day 5
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.
Device: NeuRx Diaphragm Pacing System (DPS)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and procedure safety
Time Frame: Through study completion, an average of 6 years
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
Through study completion, an average of 6 years
Monitoring
Time Frame: Through study completion, an average of 6 years
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Through study completion, an average of 6 years
Stimulation
Time Frame: Through study completion, an average of 6 years
Increase in magnitude of diaphragm burst activity with stimulation
Through study completion, an average of 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of diaphragm stimulation
Time Frame: Through study completion, an average of 6 years
Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay
Through study completion, an average of 6 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrode removal
Time Frame: Through study completion, an average of 6 years
(3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first
Through study completion, an average of 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synapse Biomedical

Investigators

  • Principal Investigator: Tunç Laçin, MD, Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2016

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN 20-1000-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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