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

Sponsor

University of Louisville (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04115501

Collaborator

Peking Union Medical College Hospital (Other), Tianjin Chest Hospital (Other), Xiangya Hospital of Central South University (Other), Guangdong Provincial People's Hospital (Other), Second Xiangya Hospital of Central South University (Other), Peking University People's Hospital (Other)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Injury Pulmonary Complication	Other: Fraction of Inspired Oxygen	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

arterial PO2/FiO2 Ratio [48hr post operation]
minimal postoperative arterial PO2/FiO2 Ratio

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jewish Hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville
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

Investigators

Principal Investigator: Jiapeng Huang, MD, PhD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiapeng Huang, Principal Investigator, University of Louisville

ClinicalTrials.gov Identifier:

NCT04115501

Other Study ID Numbers:

19.0988

First Posted:

Oct 4, 2019

Last Update Posted:

Jul 30, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Injury

Wounds and Injuries

Study Results

No Results Posted as of Jul 30, 2021