Oxygen Reserve Index to Reduce Hyperoxia

Not Applicable

Completed

• Conditions: Hyperoxemia
• Interventions: Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2; Procedure: Titration of fraction of inspired oxygen (FiO2) guided by SpO2

• Registration Number: NCT04211246
• Lead Sponsor: Eunah Cho, MD

Brief Summary

Excessive oxygen administration is known to cause oxidative stress, and absorption atelectasis. Hyperoxia is very common in general anesthesia settings. Even though there are concerns in using excessive oxygen during general anesthesia, the optimal fraction of inspired oxygen (FiO2) for general anesthesia is not well studied.

The oxygen reserve index (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 critically ill patients in the intensive care unit, as well as in general anesthesia.

The aim of this study is to evaluate efficacy of oxygen reserve index to reduce hyperoxemia in major abdominal surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-26
• Study Start: 2020-10-07
• Status Verified: 2022-03
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
• Patients who are scheduled for invasive arterial cannulation during surgery.

Exclusion Criteria

• Abnormal pulmonary function test
• Pregnancy
• Saturation of oxygen (SpO2) is below 92% in room air

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORI group	Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2	Fraction of inspired oxygen (FiO2) is titrated guided by SpO2 and ORI
Standard group	Titration of fraction of inspired oxygen (FiO2) guided by SpO2	Fraction of inspired oxygen (FiO2) is titrated guided by SpO2.

Primary Outcome Measures

Name	Time	Method
Pressure of arterial oxygen (PaO2) after 1 hour of surgery.	After 1 hour of surgery	Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

Secondary Outcome Measures

Name	Time	Method
Pressure of arterial oxygen (PaO2) after 3 hours of surgery.	After 3 hours of surgery	Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Pressure of arterial oxygen (PaO2) after 2 hours of surgery.	After 2 hours of surgery	Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Minimal and maximal value of PaO2 throughout the surgery	1 hour after the end of surgery	Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Oxygen reserve index (ORI)	1 hour after the end of surgery	Oxygen reserve idex shown from the monitoring device during the surgery
Fraction of inspired oxygen (FiO2)	1 hour after the end of surgery	Fraction of inspired oxygen (FiO2) administered during the surgery

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of