Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Interventions
- Device: TransAeris
- Registration Number
- NCT04899856
- Lead Sponsor
- Synapse Biomedical
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control / Crossover to TransAeris Therapy TransAeris 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 with TransAeris Therapy TransAeris 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.
- Primary Outcome Measures
Name Time Method Number of subjects experiencing serious device-related adverse effects 60 days after implantation All participants will be assessed for serious device-related adverse effects
Proportion of subjects weaned at 48 hours and 120 hours 90 days after study completion Time on mechanical ventilation will be compared between the Control and Treatment groups
- Secondary Outcome Measures
Name Time Method Average number of days in the Intensive Care Unit (ICU) 90 days after study completion Time in the ICU will be tracked for all study participants and averaged
Number of subjects experiencing device-related adverse events 90 days after study completion All participants will be assessed for device-related adverse events
Average number of days in the hospital 90 days after study completion Time in the hospital will be tracked for all study participants and averaged
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States