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The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.

Primary Purpose

Hyperoxia, Complication, Mechanical Ventilation 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
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 focused on measuring Hyperoxia, Fraction of inspired oxygen, Intensive care unit

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients older than 18 years, Patients whose oxygen saturation >97% Patients that have invasive arterial monitorization 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

No Intervention

Active Comparator

Arm Label

Control group

ORi+SpO2 (oxygen saturation) group

Arm Description

Patients with oxygen saturation > 97% will only be observed. ORi values will be recorded blindly from the clinician. Adjustments to be made in FiO2 will be determined by the intensive care doctor independently of the study, and only observation will be made in this group.

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

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

Secondary Outcome Measures

Fraction of inspired oxygen (FiO2)
Fraction of inspired oxygen (FiO2) in every 4 hour intervals
Mean arterial blood pressure (MAP)
Measurement of mean arteria blood pressure (SBP)
Heart rate (HR)
Measurement of heart rate (HR)
Positive end-expiratory pressure (PEEP)
Measurement of PEEP

Full Information

First Posted
March 15, 2023
Last Updated
March 29, 2023
Sponsor
Tepecik Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05807815
Brief Title
The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.
Official Title
Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia in Mechanically Ventilated Patients in the Intensive Care Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 13, 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 in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. 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. 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, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.
Detailed Description
In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. 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, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia, Complication, Mechanical Ventilation Complication
Keywords
Hyperoxia, Fraction of inspired oxygen, Intensive care unit

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients with oxygen saturation > 97% will only be observed. ORi values will be recorded blindly from the clinician. Adjustments to be made in FiO2 will be determined by the intensive care doctor independently of the study, and only observation will be made in this group.
Arm Title
ORi+SpO2 (oxygen saturation) 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
Intervention Type
Procedure
Intervention Name(s)
Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
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
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
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Fraction of inspired oxygen (FiO2)
Description
Fraction of inspired oxygen (FiO2) in every 4 hour intervals
Time Frame
Up to 48 hours
Title
Mean arterial blood pressure (MAP)
Description
Measurement of mean arteria blood pressure (SBP)
Time Frame
Up to 48 hours
Title
Heart rate (HR)
Description
Measurement of heart rate (HR)
Time Frame
Up to 48 hours
Title
Positive end-expiratory pressure (PEEP)
Description
Measurement of PEEP
Time Frame
Up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years, Patients whose oxygen saturation >97% Patients that have invasive arterial monitorization 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
20878146
Citation
de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28.
Results Reference
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PubMed Identifier
24164953
Citation
Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
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
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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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
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The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.

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