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Clinical Trials/NCT04115501
NCT04115501
Withdrawn
Not Applicable

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

University of Louisville1 site in 1 countryFebruary 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Injury
Sponsor
University of Louisville
Locations
1
Primary Endpoint
arterial PO2/FiO2 Ratio
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 27, 2021
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jiapeng Huang

Principal Investigator

University of Louisville

Eligibility Criteria

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,

Outcomes

Primary Outcomes

arterial PO2/FiO2 Ratio

Time Frame: 48hr post operation

minimal postoperative arterial PO2/FiO2 Ratio

Secondary Outcomes

  • Pulmonary complications(up to one week while in the hospital)
  • length of mechanical ventilation(up to one week while in the hospital)
  • length of hospital stay(up to one week while in the hospital)
  • length of postoperative ICU stay(up to one week while in the hospital)

Study Sites (1)

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