Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Tr⦠(NCT04978636) | Clinical Trial Compass
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Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
United States5,502 participantsStarted 2021-09-20
Plain-language summary
This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* \>18 years of age
* Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.
Exclusion Criteria:
Emergency surgeries, surgeries requiring lung isolation and one-lung ventilation (OLV), heart or lung transplants, and mechanical circulatory support device implantation pulmonary thrombendarterectomies.
* Surgeries requiring one-lung ventilation will be excluded because of the inability to employ study intervention and the differential treatment of the lungs likely confounding any potential effect from the planned intervention.
* Lung transplant surgeries will be excluded for similar reasons as well as other confounding effects affecting the primary composite outcome.
* Heart transplants and mechanical circulatory support device implantation surgeries will be excluded because these patients already receive intervention as part of the institutional protocol at the primary study site.
What they're measuring
1
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications