Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2022-08-17
2022-10-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group F30
In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.
Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).
Group F50
In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.
Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).
Group F80
In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.
Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).
Interventions
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Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
8 Years
ALL
Yes
Sponsors
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Baskent University Ankara Hospital
OTHER
Responsible Party
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Ahmed Uslu
Principal Investigator
Locations
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Baskent University Ankara Hospital
Ankara, Cankaya, Turkey (Türkiye)
Countries
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Other Identifiers
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2022-05/1838
Identifier Type: -
Identifier Source: org_study_id
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