Cardiac Surgery
Conditions
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.
Detailed description
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.
Interventions
OTHERContinuous 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.
OTHERContinuous 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.
OTHERApnea 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.
Sponsors
Society of Cardiovascular Anesthesiologists
University of Pittsburgh Medical Center
Ohio State University
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications | Within 30 days of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for tracheostomy | Within 30 days of surgery | Need for tracheostomy (STS defined) |
| CPB time | During surgery | Duration of cardiopulmonary bypass (STS defined) |
| ICU LOS | Within 30 days of surgery | ICU length of stay (STS defined) |
| Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission | 24 hours | PaO2/FiO2 ratio \< 200 mmHg at any time within the first 24 hours of ICU admission |
| Reintubation | Within 30 days of surgery | Reintubation (STS defined) |
| Pleural effusion requiring drainage | Within 30 days of surgery | Pleural effusion requiring drainage (STS defined) |
| Pneumonia | Within 30 days of surgery | Pneumonia (STS defined) |
| Readmission | within 30 days of surgery | Readmission due to respiratory complication or need for thoracentesis and chest tube insertion (STS defined) |
| 30-day mortality | Within 30 days of surgery | STS defined in hospital mortality |
| Hospital LOS | Within 30 days of surgery | Hospital length of stay (STS defined) |
Countries
United States
Outcome results
None listed