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Oxygen Reserve Index to Reduce Hyperoxia

Primary Purpose

Hyperoxemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Titration of fraction of inspired oxygen (FiO2) guided by SpO2
Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Sponsored by
Eunah Cho, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperoxemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
  • Patients who are scheduled for invasive arterial cannulation during surgery.

Exclusion Criteria:

  • Abnormal pulmonary function test
  • Pregnancy
  • Saturation of oxygen (SpO2) is below 92% in room air

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard group

ORI group

Arm Description

Fraction of inspired oxygen (FiO2) is titrated guided by SpO2.

Fraction of inspired oxygen (FiO2) is titrated guided by SpO2 and ORI

Outcomes

Primary Outcome Measures

Pressure of arterial oxygen (PaO2) after 1 hour of surgery.
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

Secondary Outcome Measures

Pressure of arterial oxygen (PaO2) after 2 hours of surgery.
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Pressure of arterial oxygen (PaO2) after 3 hours of surgery.
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Minimal and maximal value of PaO2 throughout the surgery
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Fraction of inspired oxygen (FiO2)
Fraction of inspired oxygen (FiO2) administered during the surgery
Oxygen reserve index (ORI)
Oxygen reserve idex shown from the monitoring device during the surgery

Full Information

First Posted
December 19, 2019
Last Updated
March 29, 2022
Sponsor
Eunah Cho, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04211246
Brief Title
Oxygen Reserve Index to Reduce Hyperoxia
Official Title
Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eunah Cho, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Excessive oxygen administration is known to cause oxidative stress, and absorption atelectasis. Hyperoxia is very common in general anesthesia settings. Even though there are concerns in using excessive oxygen during general anesthesia, the optimal fraction of inspired oxygen (FiO2) for general anesthesia is not well studied. The oxygen reserve index (ORI) is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORI that it might be helpful to reduce hyperoxia in critically ill patients in the intensive care unit, as well as in general anesthesia. The aim of this study is to evaluate efficacy of oxygen reserve index to reduce hyperoxemia in major abdominal surgery.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard group
Arm Type
Active Comparator
Arm Description
Fraction of inspired oxygen (FiO2) is titrated guided by SpO2.
Arm Title
ORI group
Arm Type
Experimental
Arm Description
Fraction of inspired oxygen (FiO2) is titrated guided by SpO2 and ORI
Intervention Type
Procedure
Intervention Name(s)
Titration of fraction of inspired oxygen (FiO2) guided by SpO2
Other Intervention Name(s)
SpO2
Intervention Description
Titration of fraction of inspired oxygen (FiO2) guided by SpO2
Intervention Type
Procedure
Intervention Name(s)
Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Other Intervention Name(s)
ORI+SpO2
Intervention Description
Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Primary Outcome Measure Information:
Title
Pressure of arterial oxygen (PaO2) after 1 hour of surgery.
Description
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Time Frame
After 1 hour of surgery
Secondary Outcome Measure Information:
Title
Pressure of arterial oxygen (PaO2) after 2 hours of surgery.
Description
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Time Frame
After 2 hours of surgery
Title
Pressure of arterial oxygen (PaO2) after 3 hours of surgery.
Description
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Time Frame
After 3 hours of surgery
Title
Minimal and maximal value of PaO2 throughout the surgery
Description
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Time Frame
1 hour after the end of surgery
Title
Fraction of inspired oxygen (FiO2)
Description
Fraction of inspired oxygen (FiO2) administered during the surgery
Time Frame
1 hour after the end of surgery
Title
Oxygen reserve index (ORI)
Description
Oxygen reserve idex shown from the monitoring device during the surgery
Time Frame
1 hour after the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for elective major abdominal surgery expected to last more than 2hours. Patients who are scheduled for invasive arterial cannulation during surgery. Exclusion Criteria: Abnormal pulmonary function test Pregnancy Saturation of oxygen (SpO2) is below 92% in room air
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36401493
Citation
Ahn JH, Shim JG, Park J, Lee SH, Ryu KH, Cho EA. Oxygen reserve index guided fraction of inspired oxygen titration to reduce hyperoxemia during laparoscopic gastrectomy: A randomized controlled trial. Medicine (Baltimore). 2022 Nov 18;101(46):e31592. doi: 10.1097/MD.0000000000031592.
Results Reference
derived

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Oxygen Reserve Index to Reduce Hyperoxia

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