NCT04457427

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 7, 2020

Status Verified

March 1, 2020

Enrollment Period

5.2 years

First QC Date

March 26, 2020

Last Update Submit

June 30, 2020

Conditions

Diaphragm IssuesVentilator-Induced Lung InjuryTracheostomy

Keywords

Mechanical VentilatorsVentilators, PulmonaryFailure to weanLung Injury, Ventilator-InducedTracheostomyDiaphragm pacing

Outcome Measures

Primary Outcomes (3)

  • 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

    Through study completion, an average of 6 years

  • Monitoring

    Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction

    Through study completion, an average of 6 years

  • Stimulation

    Increase in magnitude of diaphragm burst activity with stimulation

    Through study completion, an average of 6 years

Secondary Outcomes (1)

  • Effects of diaphragm stimulation

    Through study completion, an average of 6 years

Other Outcomes (1)

  • Electrode removal

    Through study completion, an average of 6 years

Study Arms (3)

Tracheostomy, no DPS

NO INTERVENTION

5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.

Trachesotomy with immediate DPS stimulation and monitoring

EXPERIMENTAL

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)

Trachesotomy with DPS monitoring, stimulation on day 5

ACTIVE COMPARATOR

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)

Interventions

NeuRx Diaphragm Pacing System (DPS)DEVICE

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.

Trachesotomy with DPS monitoring, stimulation on day 5Trachesotomy with immediate DPS stimulation and monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara Univeristy

Istanbul, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tunç Laçin, MD

    Marmara University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

July 7, 2020

Study Start

December 1, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

July 7, 2020

Record last verified: 2020-03

Locations

TU(1)