Status:
COMPLETED
Study of TransAeris® System for Enhanced Recovery After Surgery in France
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 a monocentric and open label randomized study in adult open cardiac surgery patients. Eligible patients from whom informed consent is obtained are enrolled in the study. All subjects wil...
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 subject
- Subject is covered by a healthcare insurance
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 (LVAD) 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
- Subject deprived of liberty
- Subject under court protection
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05404477
Start Date
June 22 2022
End Date
August 17 2023
Last Update
November 12 2024
Active Locations (1)
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1
CHU - Nantes
Nantes, France