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

NCT ID: NCT04899856

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2024-05-31

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).

Detailed Description

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.

Conditions

Ventilator Induced Diaphragm Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control / Crossover to TransAeris Therapy

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.

Group Type: OTHER

TransAeris

Intervention Type: 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.

Treatment with TransAeris Therapy

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.

Group Type: EXPERIMENTAL

TransAeris

Intervention Type: 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.

Interventions

TransAeris

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is undergoing an open cardiac procedure by median sternotomy

2. 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

3. Subject is at least 22 years of age

4. Informed consent has been obtained from the patient

Exclusion Criteria

1. Subject is on invasive mechanical ventilation prior to procedure

2. Subject has known or pre-existing phrenic nerve paralysis

3. Subject is having a left ventricular assist device implanted

4. Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm

5. Subject is pregnant or lactating

6. Subject is actively participating in another clinical study which could affect outcomes in this study

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Synapse Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond P Onders, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

20-1000-105

Identifier Type: -

Identifier Source: org_study_id