Study of TransAeris® System for Enhanced Recovery After Surgery in France (NCT05404477) | Clinical Trial Compass
CompletedNot Applicable
Study of TransAeris® System for Enhanced Recovery After Surgery in France
France30 participantsStarted 2022-06-22
Plain-language 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).
Who can participate
Age range22 Years
SexALL
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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:
✓. 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
Exclusion criteria
✕. 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