Clinical trial NCT04115501: Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
Official title: Intraoperative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Injury
Pulmonary Complication
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Tianjin Chest Hospital
name: Xiangya Hospital of Central South University
name: Guangdong Provincial People's Hospital
name: Second Xiangya Hospital of Central South University
name: Peking University People's Hospital
First posted: 2019-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: arterial PO2/FiO2 Ratio
timeFrame: 48hr post operation
Secondary outcomes:
measure: Pulmonary complications
timeFrame: up to one week while in the hospital
measure: length of mechanical ventilation
timeFrame: up to one week while in the hospital
measure: length of postoperative ICU stay
timeFrame: up to one week while in the hospital
measure: length of hospital stay
timeFrame: up to one week while in the hospital
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Jiapeng Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: