Ventilator-Induced Diaphragm Dysfunction
Conditions
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.
Interventions
DEVICETransAeris 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.
Sponsors
Synapse Biomedical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| ICU Care | 90 days after study completion | Number of instances of interference with ICU care |
| 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 |
| EMG | 90 days after study completion | EMG analysis of cross-over patients |
| Device related adverse events | 90 days after study completion | Number of Device related adverse events |
Countries
France
Outcome results
None listed