Status:
UNKNOWN
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
Lead Sponsor:
Synapse Biomedical
Conditions:
Ventilator Induced Diaphragm Dysfunction
Eligibility:
All Genders
22+ years
Phase:
NA
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04899856
Start Date
August 10 2021
End Date
May 1 2024
Last Update
August 18 2023
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106