HyperoxemiaNCT04211246
Oxygen Reserve Index to Reduce Hyperoxia
A study testing Titration of fraction of inspired oxygen (FiO2) guided by SpO2 and Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2 in people with Hyperoxemia, run by Eunah Cho, MD at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperoxemia
- What is being tested?
- Titration of fraction of inspired oxygen (FiO2) guided by SpO2 and Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2020to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
- Patients who are scheduled for invasive arterial cannulation during surgery.
Who cannot join
- Abnormal pulmonary function test
- Pregnancy
- Saturation of oxygen (SpO2) is below 92% in room air
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery
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
- Being tested
- Titration of fraction of inspired oxygen (FiO2) guided by SpO2, Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of fraction of inspired oxygen (FiO2) guided by SpO2Procedure or surgery
Also called SpO2
Titration of fraction of inspired oxygen (FiO2) guided by SpO2
Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2Procedure or surgery
Also called ORI+SpO2
Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | Fraction of inspired oxygen (FiO2) is titrated guided by SpO2. Receives: 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 Receives: Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure of arterial oxygen (PaO2) after 1 hour of surgery.
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Measured: After 1 hour of surgery
Secondary outcomes (5)
Pressure of arterial oxygen (PaO2) after 2 hours of surgery.
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Measured: After 2 hours of surgery
Pressure of arterial oxygen (PaO2) after 3 hours of surgery.
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Measured: After 3 hours of surgery
Minimal and maximal value of PaO2 throughout the surgery
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
Measured: 1 hour after the end of surgery
Fraction of inspired oxygen (FiO2)
Fraction of inspired oxygen (FiO2) administered during the surgery
Measured: 1 hour after the end of surgery
Oxygen reserve index (ORI)
Oxygen reserve idex shown from the monitoring device during the surgery
Measured: 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start7 Oct 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunah Cho, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211246
- Sponsor's protocol ID
- 2019-12-027
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36401493
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04211246
- Acronym / sponsor ID
- 2019-12-027
- Conditions
- Hyperoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eunah Cho, MDUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Procedure: Titration of fraction of inspired oxygen (FiO2) guided by SpO2Fraction of inspired oxygen (FiO2) is titrated guided by SpO2. |
| ORI group | Experimental | Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2Fraction of inspired oxygen (FiO2) is titrated guided by SpO2 and ORI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
- Patients who are scheduled for invasive arterial cannulation during surgery.
Key exclusion criteria (3 listed)
- Abnormal pulmonary function test
- Pregnancy
- Saturation of oxygen (SpO2) is below 92% in room air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration of fraction of inspired oxygen (FiO2) guided by SpO2Also: SpO2Titration of fraction of inspired oxygen (FiO2) guided by SpO2 | Procedure or surgery | Standard group |
| Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2Also: ORI+SpO2Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2 | Procedure or surgery | ORI group |
Primary outcome
Pressure of arterial oxygen (PaO2) after 1 hour of surgery.
Time frame: After 1 hour of surgery
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice.
5 secondary outcomes
Pressure of arterial oxygen (PaO2) after 2 hours of surgery.
Time frame: After 2 hours of surgery
Pressure of arterial oxygen (PaO2) after 3 hours of surgery.
Time frame: After 3 hours of surgery
Minimal and maximal value of PaO2 throughout the surgery
Time frame: 1 hour after the end of surgery
Fraction of inspired oxygen (FiO2)
Time frame: 1 hour after the end of surgery
Oxygen reserve index (ORI)
Time frame: 1 hour after the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 36401493Ahn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of fraction of inspired oxygen (FiO2) guided by SpO2 and Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2 in people with Hyperoxemia, run by Eunah Cho, MD at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure of arterial oxygen (PaO2) after 1 hour of surgery. (time frame: After 1 hour of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.