Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)

NARecruitingINTERVENTIONAL
Enrollment

5,502

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

March 30, 2027

Conditions
Cardiac Surgery
Interventions
OTHER

Continuous low-tidal volume ventilation with using FiO2 of 0.21

The continuous low-tidal volume ventilation with using FiO2 of 0.21 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 0.21 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.

OTHER

Continuous low tidal volume ventilation with using FiO2 of 1.0

The continuous low-tidal volume ventilation with using FiO2 of 1.0 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 1.0 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.

OTHER

Apnea During CPB

There will be no ventilation used. But, during the sub-study part of the Apnea CPB extra blood samples will be drawn before and after CPB.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
collaborator

Society of Cardiovascular Anesthesiologists

UNKNOWN

collaborator

University of Pittsburgh Medical Center

OTHER

collaborator

Ohio State University

OTHER

lead

The Cleveland Clinic

OTHER