FiO2 and Outcomes After OPCAB (the CARROT Trial)

NCT03945565 | Completed

• 1 other identifier: FiO2 OPCAB
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

FiO2 0.3

ACTIVE COMPARATOR

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

Other: Fraction of inspired oxygen level

FiO2 0.8

ACTIVE COMPARATOR

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

Other: Fraction of inspired oxygen level

Interventions

Fraction of inspired oxygen level 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 0.3; FiO2 0.8

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for elective off-pump coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Asan Medical Center: collaborator
• Severance Hospital: collaborator

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Nam K, Nam JS, Kim HB, Chung J, Hwang IE, Ju JW, Bae J, Lee S, Cho YJ, Shim JK, Kwak YL, Chin JH, Choi IC; CARdiac suRgery and Oxygen Therapy (CARROT) Investigators; Lee EH, Jeon Y. Effects of intraoperative inspired oxygen fraction (FiO2 0.3 vs 0.8) on patients undergoing off-pump coronary artery bypass grafting: the CARROT multicenter, cluster-randomized trial. Crit Care. 2023 Jul 13;27(1):286. doi: 10.1186/s13054-023-04558-8.

  PMID: 37443130 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yunseok Jeon

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 10, 2019
• Study Start: August 1, 2019
• Primary Completion: August 17, 2021
• Study Completion: September 12, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

KR (1)