Trial Outcomes & Findings for Electrical Activation of The Diaphragm for Ventilatory Assist (NCT NCT00010374)

NCT ID: NCT00010374

Last Updated: 2020-08-18

Results Overview

Number of enrolled subjects that successfully maintained clinically acceptable tidal volumes greater than basal requirements over a continuous 4 hour period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: Within one year after implantation
• Results posted on: 2020-08-18

Participant Flow

This study enrolled patients who have suffered from high-level spinal cord injury, are full-time dependent on positive pressure mechanical ventilation and have intact bilateral phrenic nerves.

One participant had a false positive phrenic nerve test after consent

Participant milestones

Measure	Treatment Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
Overall Study STARTED	54
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
Overall Study False positive phrenic nerve test	1

Baseline Characteristics

Electrical Activation of The Diaphragm for Ventilatory Assist

Baseline characteristics by cohort

Measure	NeuRx DPS n=53 Participants Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system. NeuRx DPS: Laparoscopic implantation of diprapagm electrode and subsequent pacing with the NeuRx DPS.
Age, Continuous	36.1 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Region of Enrollment Iceland	2 participants n=5 Participants
Time since injury	5.425 years STANDARD_DEVIATION 6.75 • n=5 Participants

PRIMARY outcome

Timeframe: Within one year after implantation

Number of enrolled subjects that successfully maintained clinically acceptable tidal volumes greater than basal requirements over a continuous 4 hour period.

Outcome measures

Measure	Treatment n=53 Participants Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period. Success: Vt>Basal Req. Continuous use > 4 hours	52 Participants
Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period. Partial success: Vt>Basal Req. max use < 4 hours	1 Participants

SECONDARY outcome

Timeframe: Within one year after implantation

Population: Participants with high level spinal cord injury that are dependent on mechanical ventilation and have intact phrenic nerves.

To evaluate the ability of NeuRx DPS therapy to replace mechanical ventilation for patients on a chronic use basis, a secondary indicator of this objective is tidal volume (Vt) measured in ml during chronic stimulation.

Outcome measures

Measure	Treatment n=53 Participants Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
Achieve Clinically Acceptable Basal Metabolic Requirement of Tidal Volume Measured in ml During Chronic Stimulation.	745.6 ml Standard Deviation 217.7

SECONDARY outcome

Timeframe: Within one year of implantation

Population: Participants with high level spinal cord injury that are dependent on mechanical ventilation and have intact phrenic nerves.

Number of patients that can achieve at least 24 hours daily use of the NeuRx DPS without the assistance of a mechanical ventilator.

Outcome measures

Measure	Treatment n=53 Participants Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
Number of Patients That Use NeuRx DPS to Breathe Without the Assistance of a Mechanical Ventilator for 24 Continuous Hours a Day	31 Participants

Adverse Events

Treatment

Serious events: 8 serious events

Other events: 38 other events

Deaths: 4 deaths

Serious adverse events

Measure	Treatment n=53 participants at risk Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
General disorders Death while device was not in use	3.8% 2/53 • Number of events 2 • 1 year from date of enrollment No details to include
General disorders Death while device was in use	3.8% 2/53 • Number of events 2 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Pneumonia	5.7% 3/53 • Number of events 10 • 1 year from date of enrollment No details to include
Renal and urinary disorders Urinary Tract Infection	3.8% 2/53 • Number of events 2 • 1 year from date of enrollment No details to include
Renal and urinary disorders Acute Polynephritis	1.9% 1/53 • Number of events 1 • 1 year from date of enrollment No details to include
Gastrointestinal disorders Cholecystitis	1.9% 1/53 • Number of events 2 • 1 year from date of enrollment No details to include
Cardiac disorders Chest Pain	1.9% 1/53 • Number of events 1 • 1 year from date of enrollment No details to include
Infections and infestations Elevated Temperature	3.8% 2/53 • Number of events 2 • 1 year from date of enrollment No details to include
Skin and subcutaneous tissue disorders Blood from and around treacheostomy tube	1.9% 1/53 • Number of events 1 • 1 year from date of enrollment No details to include

Other adverse events

Measure	Treatment n=53 participants at risk Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.
Renal and urinary disorders Urinary tract infection	11.3% 6/53 • Number of events 10 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Pneumonia	7.5% 4/53 • Number of events 7 • 1 year from date of enrollment No details to include
Musculoskeletal and connective tissue disorders Spasms	9.4% 5/53 • Number of events 5 • 1 year from date of enrollment No details to include
Musculoskeletal and connective tissue disorders Pain/discomfort with stimulation	5.7% 3/53 • Number of events 4 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Aspiration	5.7% 3/53 • Number of events 11 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Increased secretions	5.7% 3/53 • Number of events 3 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Low oxygen saturation/tidal volume	5.7% 3/53 • Number of events 5 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Capnothorax	39.6% 21/53 • Number of events 21 • 1 year from date of enrollment No details to include
Product Issues Broken External Wire	13.2% 7/53 • Number of events 12 • 1 year from date of enrollment No details to include
Product Issues External Equipment Failure	15.1% 8/53 • Number of events 10 • 1 year from date of enrollment No details to include
General disorders Elevated Temperature	5.7% 3/53 • Number of events 6 • 1 year from date of enrollment No details to include
Product Issues Broken Anode	11.3% 6/53 • Number of events 8 • 1 year from date of enrollment No details to include
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	9.4% 5/53 • Number of events 9 • 1 year from date of enrollment No details to include
Skin and subcutaneous tissue disorders Pressure Sore	5.7% 3/53 • Number of events 4 • 1 year from date of enrollment No details to include
General disorders Pain/Discomfort no device use	5.7% 3/53 • Number of events 3 • 1 year from date of enrollment No details to include

Additional Information

Anthony Ignagni

Synapse Biomedical, Inc.

Phone: 440-774-2488

Email: aignagni@synapsebiomedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place