UnknownNot Applicable

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

United States40 participantsStarted 2021-08-10

Plain-language 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).

Who can participate

Age range22 Years

SexALL

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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 patient

Exclusion criteria

✕. Subject is on invasive mechanical ventilation prior to procedure
✕. Subject has known or pre-existing phrenic nerve paralysis
✕. Subject is having a left ventricular assist device implanted
✕. 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

Number of subjects experiencing serious device-related adverse effects

Timeframe: 60 days after implantation

Proportion of subjects weaned at 48 hours and 120 hours

Timeframe: 90 days after study completion

Trial details

NCT IDNCT04899856

SponsorSynapse Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05

View on ClinicalTrials.gov More Ventilator Induced Diaphragm Dysfunction trials