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Oxygen Reserve Index to Reduce Hyperoxia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04211246
Enrollment
64
Registered
2019-12-26
Start date
2020-10-07
Completion date
2022-03-28
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperoxemia

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.

Interventions

PROCEDURETitration of fraction of inspired oxygen (FiO2) guided by SpO2

Titration of fraction of inspired oxygen (FiO2) guided by SpO2

PROCEDURETitration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2

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

Sponsors

Eunah Cho, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure of arterial oxygen (PaO2) after 1 hour of surgery.After 1 hour of surgeryPressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.

Secondary

MeasureTime frameDescription
Pressure of arterial oxygen (PaO2) after 2 hours of surgery.After 2 hours of surgeryPressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Pressure of arterial oxygen (PaO2) after 3 hours of surgery.After 3 hours of surgeryPressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Minimal and maximal value of PaO2 throughout the surgery1 hour after the end of surgeryPressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Fraction of inspired oxygen (FiO2)1 hour after the end of surgeryFraction of inspired oxygen (FiO2) administered during the surgery
Oxygen reserve index (ORI)1 hour after the end of surgeryOxygen reserve idex shown from the monitoring device during the surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026