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

Ventilator-Induced Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04457427
• Other study ID #: CLIN 20-1000-35
• Status: Withdrawn
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 2022

Study information

• Verified date: March 2020
• Source: Synapse Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Issues
• Lung Injury
• Tracheostomy
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara Univeristy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Synapse Biomedical

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electrode removal	(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
Primary	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
Primary	Monitoring	Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction	Through study completion, an average of 6 years
Primary	Stimulation	Increase in magnitude of diaphragm burst activity with stimulation	Through study completion, an average of 6 years
Secondary	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	Through study completion, an average of 6 years

External Links

•   Click here for more information about the Sponsor.