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

Not Applicable

Withdrawn

• Conditions: Lung Injury; Pulmonary Complication
• Interventions: Other: Fraction of Inspired Oxygen

• Registration Number: NCT04115501
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Study Start: 2021-02-27
• Status Verified: 2024-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive Oxygen	Fraction of Inspired Oxygen	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.

Primary Outcome Measures

Name	Time	Method
arterial PO2/FiO2 Ratio	48hr post operation	minimal postoperative arterial PO2/FiO2 Ratio

Secondary Outcome Measures

Name	Time	Method
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 hospital stay	up to one week while in the hospital	time from surgery day to discharge from ICU
length of postoperative ICU stay	up to one week while in the hospital	time from ICU entry to discharge from ICU

Trial Locations

Locations (1)

Jewish Hospital; 🇺🇸 Louisville, Kentucky, United States