FiO2 and Outcomes After OPCAB (the CARROT Trial)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

NCT00889811

Ischemic Heart Disease

COMPLETED PHASE1

Off-Pump and On-Pump Techniques and Oxidative Stress in CABG Surgery

NCT04834219

Cerebral Oxygenation Oxidative Stress Myocardial Infarction

COMPLETED

Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft

NCT00953368

Ischemic Heart Disease

UNKNOWN PHASE1

Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

NCT00137527

Neurological Manifestations

TERMINATED NA

High Frequency Ventilation During Off Pump Coronary Artery Bypass Graft (CABG)

NCT00863044

Coronary Artery Bypass Graft

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FiO2 0.3

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

Group Type ACTIVE_COMPARATOR

Fraction of inspired oxygen level

Intervention Type OTHER

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.

FiO2 0.8

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

Group Type ACTIVE_COMPARATOR

Fraction of inspired oxygen level

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No