Oxygen Reserve Index and Prevention of Hyperoxemia

Hyperoxia Clinical Trial

Official title:

Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505032
• Other study ID #: 2022-05/1838
• Status: Completed
• Phase: Phase 4
• Start date: August 17, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: May 2023
• Source: Baskent University Ankara Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• Patients with an American Society of Anesthesiologists (ASA) score of 1

Exclusion Criteria:

• Patients with an American Society of Anesthesiologists (ASA) score of 2 and above

Related Conditions & MeSH terms

• Hyperoxemia
• Hyperoxia
• Oxygen Reserve Index
• Respiratory Aspiration

Intervention

Drug:
• Oxygen
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.

Device:
• Masimo Root Radical 7
We use it to measure the oxygen reserve index (ORi).

Locations

Country	Name	City	State
Turkey	Baskent University Ankara Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University Ankara Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FiO2 threshold value	Correlation of FiO2 threshold value and ORi value	Until the surgery is over