Ventilator Induced Diaphragm Dysfunction
Conditions
Keywords
VIDD
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 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.
Interventions
DEVICETransAeris
TransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to prevent and treat VIDD.
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: * Prior open cardiac surgery * Left Ventricular Ejection Fraction (LVEF) ≤ 30% * History of TIA or CVA * Pre-operative or anticipated intraoperative intra-aortic balloon pump * History of COPD 3. Subject is at least 22 years of age 4. Informed consent has been obtained from the patient
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects experiencing serious device-related adverse effects | 60 days after implantation | All participants will be assessed for serious device-related adverse effects |
| Proportion of subjects weaned at 48 hours and 120 hours | 90 days after study completion | Time on mechanical ventilation will be compared between the Control and Treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects experiencing device-related adverse events | 90 days after study completion | All participants will be assessed for device-related adverse events |
| Average number of days in the Intensive Care Unit (ICU) | 90 days after study completion | Time in the ICU will be tracked for all study participants and averaged |
| Average number of days in the hospital | 90 days after study completion | Time in the hospital will be tracked for all study participants and averaged |
Countries
United States
Outcome results
None listed