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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Tianjin Chest Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Guangdong Provincial People's Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive Oxygen | Experimental | The restrictive oxygen patients' Fraction of Inspired Oxygen (FiO2) will be set at a minimum of 0.3 to maintain their oxygen saturations (SpO2) greater than or equal to 95% intraoperatively. During CPB a blended air/oxygen mixture will be titrated to arterial blood gas analysis with aim of maintenance of PaO2 between 100 and 150 mmHg. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation. |
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| Liberal Oxygen | No Intervention | The liberal oxygen group will consist of subjects exposed to a Fraction of Inspired Oxygen (FiO2) set at 1.0 throughout the intraoperative period, including during cardiopulmonary bypass. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fraction of Inspired Oxygen | Other | Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| arterial PO2/FiO2 Ratio | minimal postoperative arterial PO2/FiO2 Ratio | 48hr post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary complications | ARDS, noncardiogenic pulmonary edema, pulmonary infection, pneumonia, pleural effusion, atelectasis, and respiratory failure are secondary endpoints | up to one week while in the hospital |
| length of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiapeng Huang, MD, PhD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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| OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Peking University People's Hospital | OTHER |
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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.
time from skin closure to extubation
| up to one week while in the hospital |
| length of postoperative ICU stay | time from ICU entry to discharge from ICU | up to one week while in the hospital |
| length of hospital stay | time from surgery day to discharge from ICU | up to one week while in the hospital |