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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Injury; Pulmonary Complication
• Intervention / Treatment: Other: Fraction of Inspired Oxygen

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restrictive 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.	Other: Fraction of Inspired Oxygen; Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass
No Intervention: Liberal Oxygen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial PO2/FiO2 Ratio	minimal postoperative arterial PO2/FiO2 Ratio	48hr post operation

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Xiangya Hospital of Central South University; Peking University People's Hospital; Peking Union Medical College Hospital; Guangdong Provincial People's Hospital; Second Xiangya Hospital of Central South University; Tianjin Chest Hospital
• Investigators: Principal Investigator: Jiapeng Huang, MD, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2021
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Lung Injury
• Other Study ID Numbers: 19.0988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No