Oxygen Reserve Index to Reduce Hyperoxia

NCT04211246 | Completed DMC

• 1 other identifier: 2019-12-027
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pressure of arterial oxygen (PaO2) after 2 hours of surgery.

  After 2 hours of surgery

• Pressure of arterial oxygen (PaO2) after 3 hours of surgery.

  After 3 hours of surgery

• Minimal and maximal value of PaO2 throughout the surgery

  1 hour after the end of surgery

• Fraction of inspired oxygen (FiO2)

  1 hour after the end of surgery

• Oxygen reserve index (ORI)

  1 hour after the end of surgery

Study Arms (2)

Standard group

ACTIVE COMPARATOR

Fraction of inspired oxygen (FiO2) is titrated guided by SpO2.

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

ORI group

EXPERIMENTAL

Fraction of inspired oxygen (FiO2) is titrated guided by SpO2 and ORI

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

Interventions

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

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

Also known as: SpO2

Standard group

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

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

Also known as: ORI+SpO2

ORI group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eunah Cho, MD: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Related Publications (1)

• Ahn JH, Shim JG, Park J, Lee SH, Ryu KH, Cho EA. Oxygen reserve index guided fraction of inspired oxygen titration to reduce hyperoxemia during laparoscopic gastrectomy: A randomized controlled trial. Medicine (Baltimore). 2022 Nov 18;101(46):e31592. doi: 10.1097/MD.0000000000031592.

  PMID: 36401493 DERIVED

MeSH Terms

Interventions

Oxygen Saturation

Intervention Hierarchy (Ancestors)

Metabolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: October 7, 2020
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

KR (1)