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The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

Primary Purpose

Hyperoxia, Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
SpO2 (oxygen saturation)
Sponsored by
Tepecik Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperoxia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients older than 18, Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours Patients that have invasive arterial monitorization American Society of Anesthesiologists physical class I, II or III. Exclusion Criteria: Patients younger than 18 Patients that need to be treated with high doses of vasopressors, Patients having peripheric hypoperfusion, Hemodynamically unstable patients, Patients with hemoglobinopathy, Pregnancy, Morbid obesity (bmi>40 kg/m2), Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome Acute respiratory failure or ARDS.

Sites / Locations

  • Tepecik Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

ORi+SpO2 (oxygen saturation) group

Arm Description

Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98

FiO2 will be titrated by reducing 10% if Ori>0.01 andSpO2 ≥ 98% until Ori is 0.00. FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg

Outcomes

Primary Outcome Measures

Correlation of FiO2 and ORi value
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
Correlation of PaO2 and ORİ value
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over

Secondary Outcome Measures

Fraction of inspired oxygen (FiO2)
Fraction of inspired oxygen (FiO2) administered during the surgery
Systolic blood pressure (SBP)
Measurement of systolic blood pressure (SBP)
Diastolic blood pressure (DBP)
Measurement of diastolic blood pressure (DBP)
Heart rate (HR)
Measurement of heart rate (HR)
Positive end-expiratory pressure (PEEP)
Measurement of PEEP

Full Information

First Posted
March 5, 2023
Last Updated
March 14, 2023
Sponsor
Tepecik Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05770583
Brief Title
The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
Official Title
Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
March 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tepecik Training and Research Hospital

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
Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently. Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. 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 general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98
Arm Title
ORi+SpO2 (oxygen saturation) group
Arm Type
Experimental
Arm Description
FiO2 will be titrated by reducing 10% if Ori>0.01 andSpO2 ≥ 98% until Ori is 0.00. FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg
Intervention Type
Procedure
Intervention Name(s)
Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
Other Intervention Name(s)
ORİ+SpO2
Intervention Description
FiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00. FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg
Intervention Type
Procedure
Intervention Name(s)
SpO2 (oxygen saturation)
Intervention Description
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98
Primary Outcome Measure Information:
Title
Correlation of FiO2 and ORi value
Description
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
Time Frame
Until the surgery is over
Title
Correlation of PaO2 and ORİ value
Description
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over
Time Frame
Until surgery is over
Secondary Outcome Measure Information:
Title
Fraction of inspired oxygen (FiO2)
Description
Fraction of inspired oxygen (FiO2) administered during the surgery
Time Frame
First 10 th min after intubation and every hour until surgery is over
Title
Systolic blood pressure (SBP)
Description
Measurement of systolic blood pressure (SBP)
Time Frame
First 10 th min after intubation and every hour until surgery is over
Title
Diastolic blood pressure (DBP)
Description
Measurement of diastolic blood pressure (DBP)
Time Frame
First 10 th min after intubation and every hour until surgery is over
Title
Heart rate (HR)
Description
Measurement of heart rate (HR)
Time Frame
First 10 th min after intubation and every hour until surgery is over
Title
Positive end-expiratory pressure (PEEP)
Description
Measurement of PEEP
Time Frame
First 10 th min after intubation and every hour until surgery is over

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18, Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours Patients that have invasive arterial monitorization American Society of Anesthesiologists physical class I, II or III. Exclusion Criteria: Patients younger than 18 Patients that need to be treated with high doses of vasopressors, Patients having peripheric hypoperfusion, Hemodynamically unstable patients, Patients with hemoglobinopathy, Pregnancy, Morbid obesity (bmi>40 kg/m2), Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome Acute respiratory failure or ARDS.
Facility Information:
Facility Name
Tepecik Research and Training Hospital
City
Izmir
State/Province
Konak
ZIP/Postal Code
35110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32454913
Citation
Pala Cifci S, Urcan Tapan Y, Turemis Erkul B, Savran Y, Comert B. The Impact of Hyperoxia on Outcome of Patients Treated with Noninvasive Respiratory Support. Can Respir J. 2020 May 6;2020:3953280. doi: 10.1155/2020/3953280. eCollection 2020.
Results Reference
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PubMed Identifier
21994818
Citation
Mach WJ, Thimmesch AR, Pierce JT, Pierce JD. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011;2011:260482. doi: 10.1155/2011/260482. Epub 2011 Jun 5.
Results Reference
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PubMed Identifier
30138170
Citation
Vos JJ, Willems CH, van Amsterdam K, van den Berg JP, Spanjersberg R, Struys MMRF, Scheeren TWL. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 2019 Aug;129(2):409-415. doi: 10.1213/ANE.0000000000003706.
Results Reference
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PubMed Identifier
31227971
Citation
Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S, Murakawa M. Adjustment of oxygen reserve index (ORi) to avoid excessive hyperoxia during general anesthesia. J Clin Monit Comput. 2020 Jun;34(3):509-514. doi: 10.1007/s10877-019-00341-9. Epub 2019 Jun 22.
Results Reference
background
PubMed Identifier
29445905
Citation
Scheeren TWL, Belda FJ, Perel A. Correction to: The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):579-580. doi: 10.1007/s10877-018-0104-9.
Results Reference
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The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

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