Oxygen Reserve Index and Prevention of Hyperoxemia
Primary Purpose
Hyperoxemia, Oxygen Reserve Index, Hyperoxia
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Oxygen
Masimo Root Radical 7
Sponsored by
About this trial
This is an interventional prevention trial for Hyperoxemia focused on measuring Oxygen Reserve Index, Hyperoxemia, Hyperoxia, Fraction of Inspired Oxygen
Eligibility Criteria
Inclusion Criteria:
- Patients with an American Society of Anesthesiologists (ASA) score of 1
Exclusion Criteria:
- Patients with an American Society of Anesthesiologists (ASA) score of 2 and above
Sites / Locations
- Baskent University Ankara Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group F30
Group F50
Group F80
Arm Description
In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.
In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.
In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.
Outcomes
Primary Outcome Measures
FiO2 threshold value
Correlation of FiO2 threshold value and ORi value
Secondary Outcome Measures
Full Information
NCT ID
NCT05505032
First Posted
August 15, 2022
Last Updated
May 19, 2023
Sponsor
Baskent University Ankara Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05505032
Brief Title
Oxygen Reserve Index and Prevention of Hyperoxemia
Official Title
Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University Ankara Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.
As stated in the literature, hyperoxemia has positive effects in general anesthesia and intensive care, as well as negative effects such as increased inflammation, oxidative stress and ischemia-reperfusion. In addition, acute lung injury, development of atelectasis, increased mortality, and critical illness rates have been associated with hyperoxemia in many publications. The only way the investigators can use to measure the level of hyperoxemia seems to be arterial blood gas analysis, and this method limits the investigators use because it is invasive. The Oxygen Reserve Index (ORi™) (Masimo Corp., Irvine, CA, USA) is a variable related to real-time oxygenation reserve status in the mildly hyperoxemic range (approximately 100 - 200 mmHg PaO2). ORi can be defined as a multi-wavelength, noninvasive pulse co-oximetry sensor. ORi is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) depending on the oxygenation reserve status.
There are very few studies in the literature using ORi to detect hyperoxemia. The investigators thought that if FiO2 levels used in preoxygenation, anesthesia maintenance and recovery stages in day surgeries were correlated with ORi levels, a threshold value could be determined for FiO2 levels during anesthesia stages in cases where invasive arterial blood gas could not be followed.
This study aims to determine the relationship between SpO2, FiO2 and ORi during general anesthesia, to investigate the usefulness of ORi in determining the FiO2 threshold value during anesthesia stages as an indicator of hyperoxemia, and to investigate the effects of these values on the hemodynamics, recovery, agitation and nausea-vomiting states of the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxemia, Oxygen Reserve Index, Hyperoxia, Fraction of Inspired Oxygen
Keywords
Oxygen Reserve Index, Hyperoxemia, Hyperoxia, Fraction of Inspired Oxygen
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Group F30 : FiO2 value is %30 Group F50 : FiO2 value is %50 Group F80 : FiO2 value is %80
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group F30
Arm Type
Experimental
Arm Description
In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.
Arm Title
Group F50
Arm Type
Experimental
Arm Description
In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.
Arm Title
Group F80
Arm Type
Experimental
Arm Description
In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Intervention Type
Device
Intervention Name(s)
Masimo Root Radical 7
Intervention Description
We use it to measure the oxygen reserve index (ORi).
Primary Outcome Measure Information:
Title
FiO2 threshold value
Description
Correlation of FiO2 threshold value and ORi value
Time Frame
Until the surgery is over
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with an American Society of Anesthesiologists (ASA) score of 1
Exclusion Criteria:
Patients with an American Society of Anesthesiologists (ASA) score of 2 and above
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06490
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Oxygen Reserve Index and Prevention of Hyperoxemia
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