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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-27

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Injury Pulmonary Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The research fellows and ICU physicians who record and assess the primary and secondary outcomes will be blinded to the group assignment. The principal investigator (PI) of every center and the physicians who conduct the anesthesia and monitoring intraoperatively in operating room are unblinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Fraction of Inspired Oxygen

Intervention Type OTHER

Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fraction of Inspired Oxygen

Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No