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

Synapse Biomedical

Status: Active, not recruiting

Conditions: Ventilator Induced Diaphragm Dysfunction

Treatments: Device: TransAeris

Study type: Interventional

Funder types: Industry

Identifiers

NCT04899856

20-1000-105

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control / Crossover to TransAeris Therapy

Other group

Description:

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.

Treatment:

Device: TransAeris

Treatment with TransAeris Therapy

Experimental group

Description:

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.

Treatment:

Device: TransAeris