Oxygen Reserve IndexNCT06649279
Oxygen Reserve Index in Different Fresh Gas Flow
An observational study of Oxygen Reserve Index, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Our primary objective is to determine whether oxygen reserve index ORI can be a reliable and sensitive indicator of hypoxia and hyperoxia in low-flow anesthesia settings. Our secondary objective is to investigate the ORI changes during preoxygenation stage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oxygen Reserve Index
- What is being tested?
- Oxygen reserve index
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Aug 2024
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective ear, nose, throat surgery.
Who may be able to join
- ASA I-III patients
- 18-75 years old
- underwent general anesthesia
- elective ear, nose and throat surgery, lasting longer than 60 minutes
Who cannot join
- who did not consent to participate,
- those with finger deformities
- unregulated diabetes mellitus, severe heart, kidney, or liver failure, sensitivities to local anesthetics or opioids, those who were morbidly obese (BMI \>40 kg/m²), and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54290
About this study
Official title: Variations in Oxygen Reserve Index in Different Fresh Gas Flow Rate
Our primary objective is to determine whether oxygen reserve index ORI can be a reliable and sensitive indicator of hypoxia and hyperoxia in low-flow anesthesia settings. Our secondary objective is to investigate the ORI changes during preoxygenation stage.
- Conditions
- Oxygen Reserve Index
- Being tested
- Oxygen reserve index
- Keywords
- Oxygen reserve index, Minimal flow anesthesia, High flow anesthesia, Hypoxia, Hyperoxia
- Medical subject headings
- Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen reserve indexDevice
Measuring oxygen reserve index during preoxygenation and under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group H | High Flow Anesthesia Group Receives: Device: Oxygen reserve index | |
| Group M | Minimal Flow Anesthesia Group Receives: Device: Oxygen reserve index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Reserve Index Value
The Oxygen Reserve Index (ORI) is a real-time monitoring measure that captures the oxygen reserve status in the moderate hyperoxic range (PaO2 approximately 100 to 200 mmHg). ORI provides early warning of potential oxygenation disturbances before any changes occur in SpO2 and indicates the response to oxygen therapy. ORI ranges from 1 (high reserve) to 0 (no reserve) and measures changes in mixed venous oxygen saturation (SvO2) optically after arterial oxygen saturation reaches 100%.
Measured: For each patient, from preoxygenation stage to the end of the general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Reserve IndexStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Kaya, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649279
- Sponsor's protocol ID
- E16214662-050.01.04-8172-213
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations in Oxygen Reserve Index in Different Fresh Gas Flow Rate
- ClinicalTrials.gov ID
- NCT06649279
- Acronym / sponsor ID
- E16214662-050.01.04-8172-213
- Conditions
- Oxygen Reserve Index
- Keywords
- Oxygen reserve index, Minimal flow anesthesia, High flow anesthesia, Hypoxia, Hyperoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Oct 2024 (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.
Our primary objective is to determine whether oxygen reserve index ORI can be a reliable and sensitive indicator of hypoxia and hyperoxia in low-flow anesthesia settings. Our secondary objective is to investigate the ORI changes during preoxygenation stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group H | – | Device: Oxygen reserve indexHigh Flow Anesthesia Group |
| Group M | – | Device: Oxygen reserve indexMinimal Flow Anesthesia Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective ear, nose, throat surgery.
Key inclusion criteria (4 listed)
- ASA I-III patients
- 18-75 years old
- underwent general anesthesia
- elective ear, nose and throat surgery, lasting longer than 60 minutes
Key exclusion criteria (3 listed)
- who did not consent to participate,
- those with finger deformities
- unregulated diabetes mellitus, severe heart, kidney, or liver failure, sensitivities to local anesthetics or opioids, those who were morbidly obese (BMI \>40 kg/m²), and breastfeeding women.
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 |
|---|---|---|
| Oxygen reserve indexMeasuring oxygen reserve index during preoxygenation and under general anesthesia | Device | Group H, Group M |
Primary outcome
Oxygen Reserve Index Value
Time frame: For each patient, from preoxygenation stage to the end of the general anesthesia
The Oxygen Reserve Index (ORI) is a real-time monitoring measure that captures the oxygen reserve status in the moderate hyperoxic range (PaO2 approximately 100 to 200 mmHg). ORI provides early warning of potential oxygenation disturbances before any changes occur in SpO2 and indicates the response to oxygen therapy. ORI ranges from 1 (high reserve) to 0 (no reserve) and measures changes in mixed venous oxygen saturation (SvO2) optically after arterial oxygen saturation reaches 100%.
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 18 Oct 2024.
- 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?
An observational study of Oxygen Reserve Index, run by Sakarya University 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 4 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 18 Oct 2024. 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.
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?
Oxygen Reserve Index Value (time frame: For each patient, from preoxygenation stage to the end of the general anesthesia). 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 18 Oct 2024.