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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
CHU - Nantes
Nantes, France
Serious device-related adverse events
Number of serious device-related adverse effects
Time frame: 60 days after implantation
Time on mechanical ventilation
Time measured in hours on Mechanical Ventilation and Proportion of patients weaned at 48- and 120-hours post-op
Time frame: 90 days after study completion
ICU Care
Number of instances of interference with ICU care
Time frame: 90 days after study completion
Device related adverse events
Number of Device related adverse events
Time frame: 90 days after study completion
Mortality
Mortality at 30-day post removal of electrodes
Time frame: 90 days after study completion
Mechanical ventilation time
Time on mechanical ventilation measured in hours from entry to the ICU and reversed paralytics
Time frame: 90 days after study completion
EMG
EMG analysis of cross-over patients
Time frame: 90 days after study completion
Ventilator Free Days
Number of days alive and free from mechanical ventilation
Time frame: 90 days after study completion
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Length of stay
Number of days in the ICU and in the hospital
Time frame: 90 days after study completion