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FiO2 and Outcomes After OPCAB (the CARROT Trial)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fraction of inspired oxygen level
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FiO2 0.3

FiO2 0.8

Arm Description

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

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

Outcomes

Primary Outcome Measures

hospital LOS
length of hospital stay after off-pump coronary artery bypass grafting

Secondary Outcome Measures

Full Information

First Posted
April 8, 2019
Last Updated
February 7, 2022
Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03945565
Brief Title
FiO2 and Outcomes After OPCAB (the CARROT Trial)
Official Title
Effect of Intraoperative Oxygen Tension on Patient Outcomes After Off-pump Coronary Artery Bypass Grafting (the CARROT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
September 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FiO2 0.3
Arm Type
Active Comparator
Arm Description
Patients allocated to this group are going to receiving FiO2 of 0.3 during surgery
Arm Title
FiO2 0.8
Arm Type
Active Comparator
Arm Description
Patients allocated to this group are going to receiving FiO2 of 0.8 during surgery
Intervention Type
Other
Intervention Name(s)
Fraction of inspired oxygen level
Intervention Description
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.
Primary Outcome Measure Information:
Title
hospital LOS
Description
length of hospital stay after off-pump coronary artery bypass grafting
Time Frame
From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

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FiO2 and Outcomes After OPCAB (the CARROT Trial)

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