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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Treatment with TransAeris stimulation upon completion of procedure |
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| Control | Other | Control subject will cross-over to treatment with the TransAeris System if still on mechanical ventilation at 120 hours post-op |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransAeris System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious device-related adverse events | Number of serious device-related adverse effects | 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 | 90 days after study completion |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Care | Number of instances of interference with ICU care | 90 days after study completion |
| Device related adverse events | Number of Device related adverse events |
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Inclusion Criteria:
Subject is undergoing an open cardiac procedure by median sternotomy
Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:
Subject is at least 22 years of age
Informed consent has been obtained from the subject
Subject is covered by a healthcare insurance
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles-Henri David | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU - Nantes | Nantes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41416899 | Derived | David CH, Vourc'h M, Guimbretiere G, Mugniot A, Lacoste P, Cadiet J, Rozec B, Arora R, Pelletier M, Sabik J, Onders R. Multicentre Study of Diaphragm Pacing in High-Risk Cardiac Surgery to Decrease Postoperative Mechanical Ventilation. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf472. doi: 10.1093/ejcts/ezaf472. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | Nov 5, 2024 | Prot_SAP_000.pdf |
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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.
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| 90 days after study completion |
| Mortality | Mortality at 30-day post removal of electrodes | 90 days after study completion |
| Mechanical ventilation time | Time on mechanical ventilation measured in hours from entry to the ICU and reversed paralytics | 90 days after study completion |
| EMG | EMG analysis of cross-over patients | 90 days after study completion |
| Ventilator Free Days | Number of days alive and free from mechanical ventilation | 90 days after study completion |
| Length of stay | Number of days in the ICU and in the hospital | 90 days after study completion |