Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

NCT04899856 | Unknown FDA Device

• 1 other identifier: 20-1000-105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted as a randomized 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 (2)

• Number of subjects experiencing serious device-related adverse effects

  All participants will be assessed for serious device-related adverse effects

  60 days after implantation

• Proportion of subjects weaned at 48 hours and 120 hours

  Time on mechanical ventilation will be compared between the Control and Treatment groups

  90 days after study completion

Secondary Outcomes (3)

• Number of subjects experiencing device-related adverse events

  90 days after study completion

• Average number of days in the Intensive Care Unit (ICU)

  90 days after study completion

• Average number of days in the hospital

  90 days after study completion

Study Arms (2)

Control / Crossover to TransAeris Therapy

OTHER

The "Control" group will be treated per standard hospital policy following electrode implant. If the participant is not liberated from mechanical ventilation after 120 hours (5 days), the participant will begin using TransAeris therapy. The participant will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery.

Device: TransAeris

Treatment with TransAeris Therapy

EXPERIMENTAL

The "Treatment" group will start TranAeris therapy shortly after arrival in the Intensive Care Unit (ICU). Participants will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery.

Device: TransAeris

Interventions

TransAeris DEVICE

TransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to prevent and treat VIDD.

Control / Crossover to TransAeris Therapy; Treatment with TransAeris Therapy

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 according to one or more of the following criteria:
• Prior open cardiac surgery
• Left Ventricular Ejection Fraction (LVEF) ≤ 30%
• History of TIA or CVA
• Pre-operative or anticipated intraoperative intra-aortic balloon pump
• History of COPD
• Subject is at least 22 years of age
• Informed consent has been obtained from the patient

You may not qualify if:

• Subject is on invasive mechanical ventilation prior to procedure
• Subject has known or pre-existing phrenic nerve paralysis
• Subject is having a left ventricular assist device implanted
• 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

Related Publications (1)

• David CH, Vourc'h M, Guimbretiere G, Mugniot A, Lacoste P, Cadiet J, Rozec B, Arora R, Pelletier M, Sabik J, Onders R. Multicentre Study of Diaphragm Pacing in High-Risk Cardiac Surgery to Decrease Postoperative Mechanical Ventilation. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf472. doi: 10.1093/ejcts/ezaf472.

  PMID: 41416899 DERIVED

Study Officials

• Raymond P Onders, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: August 10, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (1)