NCT05404477

Study of TransAeris® System for Enhanced Recovery After Surgery in France

Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients in France at Risk of Prolonged Mechanical Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Synapse Biomedical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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 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 will be implanted with the TransLoc electrodes during their primary surgery. Patients are randomized to treatment or control groups prior to surgical placement of the TransLoc electrodes. Comparison will be made between treatment and control patients during the initial 120 hours of study, then comparison of cross-over control patients' EMG from baseline to treatment. Further comparison of MV Time, ventilator free days and other outcome measures will be made for all patients, over the course of the 30-day treatment period, to literature on an observational basis.

Conditions

• Ventilator-Induced Diaphragm Dysfunction

Interventions

Type	Name	Description
DEVICE	TransAeris System	The TransAeris System includes four TransLoc® intramuscular diaphragm electrodes, the TransAeris external stimulator, and the FrictionLoc® connectors which provide the interface between the TransLoc electrodes and the TransAeris stimulator.

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-07-13
• Completion: 2023-08-17
• First posted: 2022-06-03
• Last updated: 2024-11-12

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study