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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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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:
Subject is at least 22 years of age
Informed consent has been obtained from the patient
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond P Onders, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41416899 | Derived | 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. |
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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.
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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 |