Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation

Completed · Not applicable

Conditions studied: Ventilator-Induced Diaphragm Dysfunction

In brief

This study will be conducted as a pilot 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).

Key facts

Study ID

NCT04309123

Run by

Synapse Biomedical

People needed

40

Starts

2020-03-30

Expected to finish

2021-04-01

Last updated by the study team

2021-04-08

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is undergoing an open cardiac procedure by median sternotomy
• Subject is at risk of prolonged mechanical ventilation ≥ 24H
• Subject is at least 22 years of age
• Informed consent has been obtained from the subject or designated representative

You may not qualify if…

• Subject is on invasive mechanical ventilation prior to procedure
• Subject has known or pre-existing phrenic nerve paralysis
• Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
• Subject is pregnant or lactating
• Subject is actively participating in another clinical study which could affect outcomes in this study

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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