Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation

NCT04309123 | Completed FDA Device

• 1 other identifier: 20-1000-100
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted as a pilot trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).

Conditions

Ventilator-Induced Diaphragm Dysfunction

Keywords

VIDD

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence of Serious Device Related Adverse Events

  60 Days

Secondary Outcomes (1)

• Duration on Mechanical Ventilation

  30 Days

Study Arms (1)

Treatment

EXPERIMENTAL

TransAeris stimulation therapy adjunctive to continued mechanical ventilation will begin 24 hours after leaving the operating room, if subject remains on mechanical ventilation. TransAeris stimulator settings (stimulus intensity, stimulus frequency, and burst on/off) will be programmed to optimize diaphragm recruitment without compromising patient comfort.

Device: TransAeris System

Interventions

TransAeris System DEVICE

The TransAeris System is a temporary percutaneous intramuscular diaphragm stimulator intended for patients at risk of or on prolonged positive pressure mechanical ventilation. TransAeris is indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD).

Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is undergoing an open cardiac procedure by median sternotomy
• Subject is at risk of prolonged mechanical ventilation ≥ 24H
• Subject is at least 22 years of age
• Informed consent has been obtained from the subject or designated representative

You may not qualify if:

• Subject is on invasive mechanical ventilation prior to procedure
• Subject has known or pre-existing phrenic nerve paralysis
• Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
• Subject is pregnant or lactating
• Subject is actively participating in another clinical study which could affect outcomes in this study

Sponsors & Collaborators

• Synapse Biomedical: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Raymond P Onders, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label observational study

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: March 30, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)