Oxygen Reserve Index and Prevention of Hyperoxemia

• Sponsor: Baskent University Ankara Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05505032
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5.7
• Patients Per Site Per Month: 17.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperoxemia; Oxygen Reserve Index; Hyperoxia; Fraction of Inspired Oxygen	Drug: Oxygen; Device: Masimo Root Radical 7	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group F30 : FiO2 value is %30 Group F50 : FiO2 value is %50 Group F80 : FiO2 value is %80Group F30 : FiO2 value is %30 Group F50 : FiO2 value is %50 Group F80 : FiO2 value is %80
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study
• Actual Study Start Date: May 10, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group F30 In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.	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).
Experimental: Group F50 In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.	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).
Experimental: Group F80 In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.	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).

Outcome Measures

Primary Outcome Measures

1. FiO2 threshold value [Until the surgery is over]

   Correlation of FiO2 threshold value and ORi value

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University Ankara Hospital	Ankara	Cankaya	Turkey	06490

Sponsors and Collaborators

• Baskent University Ankara Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Uslu, Principal Investigator, Baskent University Ankara Hospital
• ClinicalTrials.gov Identifier: NCT05505032
• Other Study ID Numbers: 2022-05/1838
• First Posted: Aug 17, 2022
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Ahmed Uslu, Principal Investigator, Baskent University Ankara Hospital: Oxygen Reserve Index; Hyperoxemia; Hyperoxia; Fraction of Inspired Oxygen
• Additional relevant MeSH terms: Respiratory Aspiration; Hyperoxia

Study Results

No Results Posted as of Aug 17, 2022