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

Ventilator Induced Diaphragm Dysfunction Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Ventilator Induced Diaphragm Dysfunction

Clinical Trial Details

NCT number	NCT04899856
Study type	Interventional
Source	Synapse Biomedical
Contact
Status	Active, not recruiting
Phase	N/A
Start date	August 10, 2021
Completion date	May 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05998018` - Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients	N/A
Completed	`NCT03096639` - Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing	N/A
Completed	`NCT03107949` - Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)	N/A
Terminated	`NCT03783884` - A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation	N/A