HyperoxemiaPhase 4NCT05505032
Oxygen Reserve Index and Prevention of Hyperoxemia
A Phase 4 study testing Oxygen and Masimo Root Radical 7 in people with Hyperoxemia and Oxygen Reserve Index, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial summary
In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperoxemia, Oxygen Reserve Index, Hyperoxia
- What is being tested?
- Oxygen and Masimo Root Radical 7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2022to 30 Oct 2022
- Phase
- Phase 4
- 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 1 year to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with an American Society of Anesthesiologists (ASA) score of 1
Who cannot join
- Patients with an American Society of Anesthesiologists (ASA) score of 2 and above
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara, Cankaya, 06490
About this study
Official title: Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study
In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.
As stated in the literature, hyperoxemia has positive effects in general anesthesia and intensive care, as well as negative effects such as increased inflammation, oxidative stress and ischemia-reperfusion. In addition, acute lung injury, development of atelectasis, increased mortality, and critical illness rates have been associated with hyperoxemia in many publications. The only way the investigators can use to measure the level of hyperoxemia seems to be arterial blood gas analysis, and this method limits the investigators use because it is invasive. The Oxygen Reserve Index (ORi™) (Masimo Corp., Irvine, CA, USA) is a variable related to real-time oxygenation reserve status in the mildly hyperoxemic range (approximately 100 - 200 mmHg PaO2). ORi can be defined as a multi-wavelength, noninvasive pulse co-oximetry sensor. ORi is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) depending on the oxygenation reserve status.
Read more
There are very few studies in the literature using ORi to detect hyperoxemia. The investigators thought that if FiO2 levels used in preoxygenation, anesthesia maintenance and recovery stages in day surgeries were correlated with ORi levels, a threshold value could be determined for FiO2 levels during anesthesia stages in cases where invasive arterial blood gas could not be followed.
This study aims to determine the relationship between SpO2, FiO2 and ORi during general anesthesia, to investigate the usefulness of ORi in determining the FiO2 threshold value during anesthesia stages as an indicator of hyperoxemia, and to investigate the effects of these values on the hemodynamics, recovery, agitation and nausea-vomiting states of the patients.
- Being tested
- Oxygen, Masimo Root Radical 7
- Keywords
- Oxygen Reserve Index, Hyperoxemia, Hyperoxia, Fraction of Inspired Oxygen
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Determination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages.
Masimo Root Radical 7Device
We use it to measure the oxygen reserve index (ORi).
| Study group | Role | What they receive |
|---|---|---|
| Group F30 | Experimental | In these patients, the FiO2 value will be adjusted to 30% in the perioperative period. Receives: Drug: Oxygen; Device: Masimo Root Radical 7 |
| Group F50 | Experimental | In these patients, the FiO2 value will be adjusted to 50% in the perioperative period. Receives: Drug: Oxygen; Device: Masimo Root Radical 7 |
| Group F80 | Experimental | In these patients, the FiO2 value will be adjusted to 80% in the perioperative period. Receives: Drug: Oxygen; Device: Masimo Root Radical 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
FiO2 threshold value
Correlation of FiO2 threshold value and ORi value
Measured: Until the surgery is over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start17 Aug 2022
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group F30 : FiO2 value is %30 Group F50 : FiO2 value is %50 Group F80 : FiO2 value is %80
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Uslu, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505032
- Sponsor's protocol ID
- 2022-05/1838
- Status last verified
- May 2023
- First submitted
- 15 Aug 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study
- ClinicalTrials.gov ID
- NCT05505032
- Acronym / sponsor ID
- 2022-05/1838
- Keywords
- Oxygen Reserve Index, Hyperoxemia, Hyperoxia, Fraction of Inspired Oxygen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 17 Aug 2022 (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.
In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.
As stated in the literature, hyperoxemia has positive effects in general anesthesia and intensive care, as well as negative effects such as increased inflammation, oxidative stress and ischemia-reperfusion. In addition, acute lung injury, development of atelectasis, increased mortality, and critical illness rates have been associated with hyperoxemia in many publications. The only way the investigators can use to measure the level of hyperoxemia seems to be arterial blood gas analysis, and this method limits the investigators use because it is invasive. The Oxygen Reserve Index (ORi™) (Masimo Corp., Irvine, CA, USA) is a variable related to real-time oxygenation reserve status in the mildly hyperoxemic range (approximately 100 - 200 mmHg PaO2). ORi can be defined as a multi-wavelength, noninvasive pulse co-oximetry sensor. ORi is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) depending on the oxygenation reserve status.
There are very few studies in the literature using ORi to detect hyperoxemia. The investigators thought that if FiO2 levels used in preoxygenation, anesthesia maintenance and recovery stages in day surgeries were correlated with ORi levels, a threshold value could be determined for FiO2 levels during anesthesia stages in cases where invasive arterial blood gas could not be followed.
This study aims to determine the relationship between SpO2, FiO2 and ORi during general anesthesia, to investigate the usefulness of ORi in determining the FiO2 threshold value during anesthesia stages as an indicator of hyperoxemia, and to investigate the effects of these values on the hemodynamics, recovery, agitation and nausea-vomiting states of the patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Group F30 : FiO2 value is %30 Group F50 : FiO2 value is %50 Group F80 : FiO2 value is %80
| Arm | Type | Receives |
|---|---|---|
| Group F30 | Experimental | Drug: Oxygen, Device: Masimo Root Radical 7In these patients, the FiO2 value will be adjusted to 30% in the perioperative period. |
| Group F50 | Experimental | Drug: Oxygen, Device: Masimo Root Radical 7In these patients, the FiO2 value will be adjusted to 50% in the perioperative period. |
| Group F80 | Experimental | Drug: Oxygen, Device: Masimo Root Radical 7In these patients, the FiO2 value will be adjusted to 80% in the perioperative period. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with an American Society of Anesthesiologists (ASA) score of 1
Key exclusion criteria (1 listed)
- Patients with an American Society of Anesthesiologists (ASA) score of 2 and above
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 |
|---|---|---|
| OxygenDetermination of FiO2 threshold value as an indicator of hyperoxemia in anesthesia stages. | Drug | Group F30, Group F50, Group F80 |
| Masimo Root Radical 7We use it to measure the oxygen reserve index (ORi). | Device | Group F30, Group F50, Group F80 |
Primary outcome
FiO2 threshold value
Time frame: Until the surgery is over
Correlation of FiO2 threshold value and ORi value
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 22 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperoxemia
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
Not yet recruiting
ORI-Guided Oxygen Therapy During One-Lung Ventilation
Thoracic Surgery With One-lung Ventilation
Not yet recruiting
Oxygen Reserve Index-Guided Oxygen Titration During Surgery in the Beach Chair Position
Hyperoxemia, Intraoperative Oxygen Therapy
Recruiting
HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics
Hyperoxemia, Cerebrovascular Circulation
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 Phase 4 study testing Oxygen and Masimo Root Radical 7 in people with Hyperoxemia and Oxygen Reserve Index, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 22 May 2023. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
FiO2 threshold value (time frame: Until the surgery is over). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.