Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery

Lung Injury Clinical Trial

Official title:

Intraoperative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04115501
• Other study ID #: 19.0988
• Status: Withdrawn
• Phase: N/A
• Start date: February 27, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Pulmonary Complication
• Wounds and Injuries

Intervention

Other:
• Fraction of Inspired Oxygen
Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass

Locations

Country	Name	City	State
United States	Jewish Hospital	Louisville	Kentucky

Sponsors (7)

Lead Sponsor	Collaborator
University of Louisville	Guangdong Provincial People's Hospital, Peking Union Medical College Hospital, Peking University People's Hospital, Second Xiangya Hospital of Central South University, Tianjin Chest Hospital, Xiangya Hospital of Central South University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial PO2/FiO2 Ratio	minimal postoperative arterial PO2/FiO2 Ratio	48hr post operation
Secondary	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
Secondary	length of mechanical ventilation	time from skin closure to extubation	up to one week while in the hospital
Secondary	length of postoperative ICU stay	time from ICU entry to discharge from ICU	up to one week while in the hospital
Secondary	length of hospital stay	time from surgery day to discharge from ICU	up to one week while in the hospital