NCT04899856

Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Synapse Biomedical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ventilator Induced Diaphragm Dysfunction

Interventions

Type	Name	Description
DEVICE	TransAeris	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.

Timeline

• Start date: 2021-08-10
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2021-05-25
• Last updated: 2023-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study