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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

Conditions
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Ventilator Induced Diaphragm Dysfunction

Intervention / Treatment
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* Device: TransAeris


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control / Crossover to TransAeris Therapy<br>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<br>* 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.<br>|
| Experimental: Treatment with TransAeris Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing device-related adverse events | All participants will be assessed for device-related adverse events | 90 days after study completion | 
| Average number of days in the Intensive Care Unit (ICU) | Time in the ICU will be tracked for all study participants and averaged | 90 days after study completion | 
| Average number of days in the hospital | Time in the hospital will be tracked for all study participants and averaged | 90 days after study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VIDD