Lung Injury, Pulmonary Complication
Conditions
Brief summary
This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury.
Detailed description
Hyperoxia is common in cardiac surgery and is easy to prevent by adjusting FiO2. Since there is no prospective study on different FiO2 and postoperative pulmonary complications (PPCs) during cardiac surgery. We hypothesized that hyperoxia during cardiac surgery could lead to higher incidence of lung injury and PPCs than normoxia. The objective of this trial is to compare postoperative PPCs and other outcomes between hyperoxia and normoxia strategy by PaO2/FiO2 in CABG patients.
Interventions
Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass
Sponsors
Peking Union Medical College Hospital
Tianjin Chest Hospital
Xiangya Hospital of Central South University
Guangdong Provincial People's Hospital
Second Xiangya Hospital of Central South University
Peking University People's Hospital
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The research fellows and ICU physicians who record and assess the primary and secondary outcomes will be blinded to the group assignment. The principal investigator (PI) of every center and the physicians who conduct the anesthesia and monitoring intraoperatively in operating room are unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 75 * BMI from 20 to 39.9 * ASA II/III * Undergoing isolated selective on-pump CABG through median sternotomy * Subsequent admission to an intensive care unit (ICU).
Exclusion criteria
* with severe chronic obstructive pulmonary disease (COPD) * Pregnant woman. * With current acute coronary syndrome (\<1 week) * Severe anemia (hemoglobin \<10g/L) * Preoperative supplemental oxygen requirement to maintain arterial O2 of 92%, * Right to left shunt in heart * Carotid stenosis defined as \>50% stenosis of either carotid artery, * Cardiac surgery that requires intraoperative circulatory arrest, * Current use of dialysis, * One-lung ventilation during surgery, * Recent smoking (within 1 month), * Non-respiratory reason to reintubate or delayed extubation such as bleeding or heart failure, * Perioperative allogenic transfusion with red blood cell, plasma or platelet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| arterial PO2/FiO2 Ratio | 48hr post operation | minimal postoperative arterial PO2/FiO2 Ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary complications | up to one week while in the hospital | ARDS, noncardiogenic pulmonary edema, pulmonary infection, pneumonia, pleural effusion, atelectasis, and respiratory failure are secondary endpoints |
| length of mechanical ventilation | up to one week while in the hospital | time from skin closure to extubation |
| length of postoperative ICU stay | up to one week while in the hospital | time from ICU entry to discharge from ICU |
| length of hospital stay | up to one week while in the hospital | time from surgery day to discharge from ICU |
Countries
United States
Outcome results
None listed