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

March 29, 2023 updated by: Aykut Saritas, Tepecik Training and Research Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Konak
      • Izmir, Konak, Turkey, 35110
        • Tepecik Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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.
Active Comparator: ORi+SpO2 (oxygen saturation) group
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98
Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of FiO2 and ORi value
Time Frame: Up to 24 weeks
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fraction of inspired oxygen (FiO2)
Time Frame: Up to 48 hours
Fraction of inspired oxygen (FiO2) in every 4 hour intervals
Up to 48 hours
Mean arterial blood pressure (MAP)
Time Frame: Up to 48 hours
Measurement of mean arteria blood pressure (SBP)
Up to 48 hours
Heart rate (HR)
Time Frame: Up to 48 hours
Measurement of heart rate (HR)
Up to 48 hours
Positive end-expiratory pressure (PEEP)
Time Frame: Up to 48 hours
Measurement of PEEP
Up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tepecik Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Health Sciences University (Gülhane Training and Research Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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