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

Not Applicable

Completed

• Conditions: Ventilator-Induced Diaphragm Dysfunction

• Registration Number: NCT05404477
• Lead Sponsor: Synapse Biomedical

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 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.

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-03
• Study Start: 2022-06-22
• Primary Completion: 2023-07-13
• Study Completion: 2023-08-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subject is undergoing an open cardiac procedure by median sternotomy

2. Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:

   1. Prior open cardiac surgery
   2. Left Ventricular Ejection Fraction (LVEF) ≤ 30%
   3. History of TIA or CVA
   4. Pre-operative or anticipated intraoperative intra-aortic balloon pump
   5. History of COPD

3. Subject is at least 22 years of age

4. Informed consent has been obtained from the subject

5. Subject is covered by a healthcare insurance

Exclusion Criteria

1. Subject is on invasive mechanical ventilation prior to procedure
2. Subject has known or pre-existing phrenic nerve paralysis
3. Subject is having a left ventricular assist device (LVAD) implanted
4. Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
5. Subject is pregnant or lactating
6. Subject is actively participating in another clinical study which could affect outcomes in this study
7. Subject deprived of liberty
8. Subject under court protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Serious device-related adverse events	60 days after implantation	Number of serious device-related adverse effects
Time on mechanical ventilation	90 days after study completion	Time measured in hours on Mechanical Ventilation and Proportion of patients weaned at 48- and 120-hours post-op

Secondary Outcome Measures

Name	Time	Method
ICU Care	90 days after study completion	Number of instances of interference with ICU care
Device related adverse events	90 days after study completion	Number of Device related adverse events
Mortality	90 days after study completion	Mortality at 30-day post removal of electrodes
Mechanical ventilation time	90 days after study completion	Time on mechanical ventilation measured in hours from entry to the ICU and reversed paralytics
EMG	90 days after study completion	EMG analysis of cross-over patients
Ventilator Free Days	90 days after study completion	Number of days alive and free from mechanical ventilation
Length of stay	90 days after study completion	Number of days in the ICU and in the hospital

Trial Locations

Locations (1)

CHU - Nantes; 🇫🇷 Nantes, France