FiO2 and Outcomes After OPCAB (the CARROT Trial)

Seoul National University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: Fraction of inspired oxygen level

Study type: Interventional

Funder types: Other

Identifiers

NCT03945565

FiO2 OPCAB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 414 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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414 participants in 2 patient groups

FiO2 0.3

Active Comparator group

Description:

Patients allocated to this group are going to receiving FiO2 of 0.3 during surgery

Treatment:

Other: Fraction of inspired oxygen level

FiO2 0.8

Active Comparator group

Description:

Patients allocated to this group are going to receiving FiO2 of 0.8 during surgery

Treatment:

Other: Fraction of inspired oxygen level