CompletedNot Applicable

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

United States40 participantsStarted 2020-03-30

Plain-language summary

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).

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Adverse Events

Timeframe: 60 Days

Trial details

NCT IDNCT04309123

SponsorSynapse Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-31

View on ClinicalTrials.gov More Ventilator-Induced Diaphragm Dysfunction trials