Status:
WITHDRAWN
Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Peking Union Medical College Hospital
Tianjin Chest Hospital
Conditions:
Lung Injury
Pulmonary Complication
Eligibility:
All Genders
18-75 years
Phase:
NA
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 complicat...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04115501
Start Date
February 27 2021
End Date
February 1 2024
Last Update
February 15 2024
Active Locations (1)
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1
Jewish Hospital
Louisville, Kentucky, United States, 40202