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

University of Louisville (UOFL)

Status: Withdrawn

Conditions: Lung Injury; Pulmonary Complication

Treatments: Other: Fraction of Inspired Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04115501

19.0988

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Restrictive Oxygen

Experimental group

Description:

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.

Treatment:

Other: Fraction of Inspired Oxygen

Liberal Oxygen

No Intervention group

Description:

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.