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

NCT04978636 | Active Not Recruiting

• 1 other identifier: 21-447
• Study Type: interventional
• Target: 5,502
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications

  Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio\<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.

  Within 30 days of surgery

Secondary Outcomes (10)

• CPB time

  During surgery

• ICU LOS

  Within 30 days of surgery

• Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission

  24 hours

• Hospital LOS

  Within 30 days of surgery

• Reintubation

  Within 30 days of surgery

Study Arms (3)

Continuous low-tidal volume ventilation with using FiO2 of 0.21

ACTIVE COMPARATOR

The investigator will investigate the effect of continuous low tidal volume ventilation with hyperoxia avoidance (using FiO2 of 0.21) on PPCs and 30-day mortality compared to low-tidal volume ventilation (with FiO2 of 0.21) or apnea during CPB, and during the sub-study.

Other: Continuous low-tidal volume ventilation with using FiO2 of 0.21

Continuous low tidal volume ventilation with using FiO2 of 1.0

ACTIVE COMPARATOR

The investigator will investigate the effect of low tidal volume lung ventilation with hyperoxia avoidance (FiO2 of 0.21) on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or apnea during CPB, and during the sub-study.

Other: Continuous low tidal volume ventilation with using FiO2 of 1.0

Apnea

ACTIVE COMPARATOR

The investigator will investigate the effect of apnea during on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or hyperoxia avoidance (FiO2 of 0.21) during CPB, and during the sub-study..

Other: Apnea During CPB

Interventions

Continuous low-tidal volume ventilation with using FiO2 of 0.21 OTHER

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.

Continuous low-tidal volume ventilation with using FiO2 of 0.21

Continuous low tidal volume ventilation with using FiO2 of 1.0 OTHER

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.

Continuous low tidal volume ventilation with using FiO2 of 1.0

Apnea During CPB OTHER

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.

Apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of Pittsburgh Medical Center: collaborator
• Ohio State University: collaborator
• Society of Cardiovascular Anesthesiologists: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Marta Kelava, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 27, 2021
• Study Start: September 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-08

Locations

US (1)