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

Synapse Biomedical

Status: Completed

Conditions: Ventilator-Induced Diaphragm Dysfunction

Treatments: Device: TransAeris System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05404477

CLIN 20-1000-108

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment

Other group

Description:

Treatment with TransAeris stimulation upon completion of procedure

Treatment:

Device: TransAeris System

Control

Other group

Description:

Control subject will cross-over to treatment with the TransAeris System if still on mechanical ventilation at 120 hours post-op

Treatment:

Device: TransAeris System