An interventional study of Continuous low-tidal volume ventilation with using FiO2 of 0.21 and Continuous low tidal volume ventilation with using FiO2 of 1.0 in Cardiac Surgery, sponsored by The Cleveland Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention
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.
The investigators will evaluate the effect of low tidal volume with varying FiO2 fractions during cardiopulmonary bypass on postoperative mortality and pulmonary complications. This will be a prospective, pragmatic, cluster randomized trial including all eligible adult cardiac surgical patients requiring cardiopulmonary bypass. Each week, all operating rooms will be randomized to one of three possible ventilation strategies during the period of cardiopulmonary bypass: 1) continuous low tidal volume ventilation with inspired oxygen fraction at 1.0, 2) continuous low tidal volume ventilation with inspired oxygen fraction at 0.21, and 3) no ventilation (apnea). The investigators will anticipate increase in plasma sRAGE and 8-iso-prostaglandin F2a levels in all three groups of patients during CPB with the highest levels immediately after cross-clamp release. The investigators will anticipate significant difference with at least 25% lower sRAGE levels in this group. The sub-study will also provide preliminary data on the behavior of the 8-iso-prostaglandin F2a which will be useful in further investigation of other targeted interventions to reduce ischemia-reperfusion injury to the lung during routine cardiac surgical operations.
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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.
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
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
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
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.
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.
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.
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.
Time frame: Within 30 days of surgery
CPB time
Duration of cardiopulmonary bypass (STS defined)
Time frame: During surgery
ICU LOS
ICU length of stay (STS defined)
Time frame: Within 30 days of surgery
Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
PaO2/FiO2 ratio \< 200 mmHg at any time within the first 24 hours of ICU admission
Time frame: 24 hours
Hospital LOS
Hospital length of stay (STS defined)
Time frame: Within 30 days of surgery
Reintubation
Reintubation (STS defined)
Time frame: Within 30 days of surgery
Need for tracheostomy
Need for tracheostomy (STS defined)
Time frame: Within 30 days of surgery
Pleural effusion requiring drainage
Pleural effusion requiring drainage (STS defined)
Time frame: Within 30 days of surgery
Pneumonia
Pneumonia (STS defined)
Time frame: Within 30 days of surgery
Readmission
Readmission due to respiratory complication or need for thoracentesis and chest tube insertion (STS defined)
Time frame: within 30 days of surgery
30-day mortality
STS defined in hospital mortality
Time frame: Within 30 days of surgery
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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