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

Primary Purpose

Lung Injury, Pulmonary Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fraction of Inspired Oxygen
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Restrictive Oxygen

Liberal Oxygen

Arm 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.

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.

Outcomes

Primary Outcome Measures

arterial PO2/FiO2 Ratio
minimal postoperative arterial PO2/FiO2 Ratio

Secondary Outcome Measures

Pulmonary complications
ARDS, noncardiogenic pulmonary edema, pulmonary infection, pneumonia, pleural effusion, atelectasis, and respiratory failure are secondary endpoints
length of mechanical ventilation
time from skin closure to extubation
length of postoperative ICU stay
time from ICU entry to discharge from ICU
length of hospital stay
time from surgery day to discharge from ICU

Full Information

First Posted
October 2, 2019
Last Updated
November 13, 2022
Sponsor
University of Louisville
Collaborators
Peking Union Medical College Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, Guangdong Provincial People's Hospital, Second Xiangya Hospital of Central South University, Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04115501
Brief Title
Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
Official Title
Intraoperative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
Peking Union Medical College Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, Guangdong Provincial People's Hospital, Second Xiangya Hospital of Central South University, Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Pulmonary Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Restrictive Oxygen
Arm Type
Experimental
Arm 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.
Arm Title
Liberal Oxygen
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Fraction of Inspired Oxygen
Intervention Description
Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass
Primary Outcome Measure Information:
Title
arterial PO2/FiO2 Ratio
Description
minimal postoperative arterial PO2/FiO2 Ratio
Time Frame
48hr post operation
Secondary Outcome Measure Information:
Title
Pulmonary complications
Description
ARDS, noncardiogenic pulmonary edema, pulmonary infection, pneumonia, pleural effusion, atelectasis, and respiratory failure are secondary endpoints
Time Frame
up to one week while in the hospital
Title
length of mechanical ventilation
Description
time from skin closure to extubation
Time Frame
up to one week while in the hospital
Title
length of postoperative ICU stay
Description
time from ICU entry to discharge from ICU
Time Frame
up to one week while in the hospital
Title
length of hospital stay
Description
time from surgery day to discharge from ICU
Time Frame
up to one week while in the hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiapeng Huang, MD, PhD
Phone
5028528157
Email
jiapeng.huang@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiapeng Huang, MD, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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