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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03945565
Other study ID # FiO2 OPCAB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date September 12, 2021

Study information

Verified date February 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery including off-pump coronary artery bypass grafting (OPCAB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery has not been reached among practitioners yet. This study is a multicenter study (Seoul National University, Asan Medical Center, Severance Hospital) where the effect of different level of FiO2 on postoperative clinical outcomes is evaluated.


Description:

A sub-study will also be conducted in part of patients of the present study. In 40 out of 500 (expected) patients, two different levels of FiO2 will be sequentially set with a 5-minute interval after the induction of general anesthesia. Mixed venous and regional cerebral oxygen saturation will then be recorded according to the change of FiO2.


Recruitment information / eligibility

Status Completed
Enrollment 414
Est. completion date September 12, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - All patients scheduled for elective off-pump coronary artery bypass grafting Exclusion Criteria: - emergency - robot-assisted surgery - minimally invasive cardiac surgery requiring thoracotomy/one-lung anesthesia - preoperative pulmonary morbidity requiring oxygen therapy - preoperative use of ECMO or IABP - preoperative tracheal intubation or mechanical ventilation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fraction of inspired oxygen level
A fraction of inspired oxygen level during off-pump coronary artery bypass grafting will be set differently between the study groups: 0.3 vs 0.8.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Seoul National University Hospital Seoul

Sponsors (3)

Lead Sponsor Collaborator
Seoul National University Hospital Asan Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary hospital LOS length of hospital stay after off-pump coronary artery bypass grafting From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks
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