Clinical trial NCT05404477: Study of TransAeris® System for Enhanced Recovery After Surgery in France
Official title: Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients in France at Risk of Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-Induced Diaphragm Dysfunction
Lead sponsor: Synapse Biomedical
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serious device-related adverse events
timeFrame: 60 days after implantation
measure: Time on mechanical ventilation
timeFrame: 90 days after study completion
Secondary outcomes:
measure: ICU Care
timeFrame: 90 days after study completion
measure: Device related adverse events
timeFrame: 90 days after study completion
measure: Mortality
timeFrame: 90 days after study completion
measure: Mechanical ventilation time
timeFrame: 90 days after study completion
measure: EMG
timeFrame: 90 days after study completion
measure: Ventilator Free Days
timeFrame: 90 days after study completion
measure: Length of stay
timeFrame: 90 days after study completion
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU - Nantes
Study officials:
affiliation: Nantes University Hospital
name: Charles-Henri David
role: PRINCIPAL_INVESTIGATOR
References: