Evaluating ventilation strategies during heart surgery
The eFfect of cOntinuous Low Tidal Volume Ventilation With Hyperoxia Avoidance During CardiopUlmonary Bypass "FOCUS" Trial Blood Samples
This study is testing different breathing methods during heart surgery to see which one helps patients recover better and have fewer complications afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5502 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04978636 on ClinicalTrials.gov |
What this trial studies
This multi-institutional study assesses the impact of different ventilation strategies during cardiopulmonary bypass on postoperative outcomes in adult cardiac surgery patients. The trial will randomly assign operating rooms to one of three ventilation methods: low tidal volume with high oxygen, low tidal volume with normal oxygen, or no ventilation at all. The study aims to measure postoperative mortality and pulmonary complications, while also investigating specific biomarkers related to lung injury. By comparing these strategies, the trial seeks to identify the most effective approach to improve patient outcomes during cardiac surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective cardiac surgeries that require cardiopulmonary bypass.
Not a fit: Patients undergoing emergency surgeries, lung transplants, or those requiring mechanical circulatory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and reduced complications for patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown varying success with different ventilation strategies during cardiac procedures, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Marta Kelava, MD — The Cleveland Clinic
- Study coordinator: Roberta Johnson
- Email: johnsor13@gmail.com
- Phone: 216/444/9950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.