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

March 14, 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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients older than 18,
  2. Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours
  3. Patients that have invasive arterial monitorization
  4. American Society of Anesthesiologists physical class I, II or III.

Exclusion Criteria:

  1. Patients younger than 18
  2. Patients that need to be treated with high doses of vasopressors,
  3. Patients having peripheric hypoperfusion,
  4. Hemodynamically unstable patients,
  5. Patients with hemoglobinopathy,
  6. Pregnancy,
  7. Morbid obesity (bmi>40 kg/m2),
  8. Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
  9. 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
Active Comparator: Control group
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98
Procedure: SpO2 (oxygen saturation)
Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95
Experimental: ORi+SpO2 (oxygen saturation) group
  • 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
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
  • FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg
Other Names:
  • ORİ+SpO2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fraction of inspired oxygen (FiO2)
Time Frame: First 10 th min after intubation and every hour until surgery is over
Fraction of inspired oxygen (FiO2) administered during the surgery
First 10 th min after intubation and every hour until surgery is over
Systolic blood pressure (SBP)
Time Frame: First 10 th min after intubation and every hour until surgery is over
Measurement of systolic blood pressure (SBP)
First 10 th min after intubation and every hour until surgery is over
Diastolic blood pressure (DBP)
Time Frame: First 10 th min after intubation and every hour until surgery is over
Measurement of diastolic blood pressure (DBP)
First 10 th min after intubation and every hour until surgery is over
Heart rate (HR)
Time Frame: First 10 th min after intubation and every hour until surgery is over
Measurement of heart rate (HR)
First 10 th min after intubation and every hour until surgery is over
Positive end-expiratory pressure (PEEP)
Time Frame: First 10 th min after intubation and every hour until surgery is over
Measurement of PEEP
First 10 th min after intubation and every hour until surgery is over

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)

September 1, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

March 5, 2023

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tepecik Training and research

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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