Status:
COMPLETED
Pilot Study of TransAeris® System in Surgical 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 pilot trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be...
Detailed Description
This pilot study is an open label observational study in adult open cardiac surgery patients. Eligible patients from whom informed consent is obtained and electrodes are successfully implanted are enr...
Eligibility Criteria
Inclusion
- Subject is undergoing an open cardiac procedure by median sternotomy
- Subject is at risk of prolonged mechanical ventilation ≥ 24H
- Subject is at least 22 years of age
- Informed consent has been obtained from the subject or designated representative
Exclusion
- Subject is on invasive mechanical ventilation prior to procedure
- Subject has known or pre-existing phrenic nerve paralysis
- 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 :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04309123
Start Date
March 30 2020
End Date
April 1 2021
Last Update
April 8 2021
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106