Oxygen Reserve Index to Reduce Hyperoxia

Hyperoxemia Clinical Trial

Official title:

Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211246
• Other study ID #: 2019-12-027
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: March 28, 2022

Study information

• Verified date: March 2022
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxemia
• Hyperoxia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eunah Cho, MD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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