FiO2 and Outcomes After OPCAB (the CARROT Trial)

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Fraction of inspired oxygen level

• Registration Number: NCT03945565
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Study Start: 2019-08-01
• Primary Completion: 2021-08-17
• Study Completion: 2021-09-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FiO2 0.8	Fraction of inspired oxygen level	Patients allocated to this group are going to receiving FiO2 of 0.8 during surgery
FiO2 0.3	Fraction of inspired oxygen level	Patients allocated to this group are going to receiving FiO2 of 0.3 during surgery

Primary Outcome Measures

Name	Time	Method
hospital LOS	From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks	length of hospital stay after off-pump coronary artery bypass grafting

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of