RhinoplastyNCT07158073
Effect of ORI-guided Oxygen Titration on Oxidative Stress in Rhinoplasty Surgery
A study testing FiO₂ titration, under the guidance of ORI and Conventional oxygen administration in people with Rhinoplasty and Oxidative Stress, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate whether the use of Oxygen Reserve Index (ORİ) can prevent hyperoxia in patients undergoing rhinoplasty surgery and whether it can reduce oxidative stress caused by hyperoxia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinoplasty, Oxidative Stress, Hyperoxia
- What is being tested?
- FiO₂ titration, under the guidance of ORI and Conventional oxygen administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- classified as ASA physical status I or II
Who cannot join
- under 18 years of age
- ASA classification greater than II
- Mallampati score of 3 or 4
- findings suggestive of difficult intubation during physical examination
- any pathological findings on chest X-ray evaluation (e.g., pleural effusion, nodular density increase, emphysema, atelectasis, calcification, mediastinal widening, or infiltration)
- a history of circulatory disorders
- hematocrit or hemoglobin values outside the normal range (Hemoglobin: 12-16 g/dL for males, 11-14 g/dL for females; Hematocrit: 36-48% for males, 33-42% for females)
- a known hypersensitivity to any anesthetic agent to be used in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, kartal, 34862
About this study
Official title: The Effect of Oxygen Reserve Index Guided Oxygen Titration on Oxidative Stress in Rhinoplasty Surgery: A Randomized Controlled Trial
The aim of this study is to evaluate whether the use of Oxygen Reserve Index (ORİ) can prevent hyperoxia in patients undergoing rhinoplasty surgery and whether it can reduce oxidative stress caused by hyperoxia.
Read the detailed description
ORI is a continuous, non-invasive parameter provided by new-generation pulse oximeters utilizing multi-wavelength pulse oximetry technology. ORI serves as an important monitoring tool for detecting both hyperoxemia and desaturation in patients with decreased PaO₂ levels. Studies have demonstrated that ORI provides values within a range of 0 to 1, and an ORI value of 0 corresponds to a PaO₂ level between 80 and 125 mmHg.
Oxygen is commonly used in clinical practice to prevent or treat hypoxia; however, excessive use may lead to oxidative stress. Oxidative stress is defined as a disruption of the oxidative balance resulting from an increased generation of reactive oxygen species (ROS) during cellular metabolism and an insufficient level of antioxidants to detoxify them. ROS are formed by the reaction of molecular oxygen with H₂O, the most stable form of oxygen. In this reaction, the stepwise addition of electrons to molecular oxygen (O₂) leads to the formation of superoxide anion (O₂ˉ), hydrogen peroxide (H₂O₂), and hydroxyl radical (-OH). Among these, the hydroxyl radical is the most reactive form of oxygen radicals.
Although ROS are essential for normal cellular functions such as intracellular signaling and defense against external threats, their excessive production can lead to molecular and cellular dysfunction. Excessive ROS attack nucleotide bases in nucleic acids, amino acid side chains in proteins, and double bonds in unsaturated fatty acids, resulting in oxidative stress that damages DNA, RNA, proteins, and lipids, leading to structural and metabolic changes in cells.
The primary aim of the investigators in this study is to determine whether ORI-guided oxygen titration during rhinoplasty surgery can help prevent hyperoxia and reduce oxidative stress compared with conventional oxygen therapy. To evaluate oxidative stress, thiol-disulfide balance and ischemia-modified albumin (IMA) levels will be assessed in the participants.
- Conditions
- Rhinoplasty, Oxidative Stress, Hyperoxia, Oxygen Reserve Index
- Being tested
- FiO₂ titration, under the guidance of ORI, Conventional oxygen administration
- Keywords
- Rhinoplasty surgery, Oxygen Reserve Index, Oxidative Stress, Hyperoxia
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiO₂ titration, under the guidance of ORIDevice
In Group R, FiO₂ was titrated between 30% and 50% under the guidance of ORI and SpO₂ values. Accordingly, if SpO₂ was ≥ 98%, FiO₂ was reduced in 5% increments to a minimum of 30%, aiming to achieve an ORI value of 0 or as close to 0 as possible.
Conventional oxygen administrationDevice
In Group C, FiO₂ was maintained at 50% throughout the surgery, provided that SpO₂ remained ≥ 98%.
| Study group | Role | What they receive |
|---|---|---|
| ORI group (Group R) | Active comparator | Patients in Group R received ORI monitoring in addition to intraoperative standart monitoring (ECG, pulse oximetry, non-invasive arterial blood pressure). For this purpose, an ORI sensor (RD Rainbow SET sensor, Masimo Corp., Irvine, CA, USA) was placed on the fourth finger of the upper extremity where there was no blood pressure cuff. The sensor was wrapped to prevent exposure to light and connected to an oximeter device (Raical-7® Pulse CO-Oximater®, Masimo Corp., Irvine, CA, USA).In Group R, mask ventilation was administered with 50% oxygen. FiO₂ was titrated between 30% and 50% under the guidance of ORI and SpO₂ values. Accordingly, if SpO₂ was ≥ 98%, FiO₂ was reduced in 5% increments to a minimum of 30%, aiming to achieve an ORI value of 0 or as close to 0 as possible. Receives: Device: FiO₂ titration, under the guidance of ORI |
| Control group (Group C) | Active comparator | Patients in Group C received only standard monitoring. Mask ventilation was administered with 100% oxygen. FiO₂ was maintained at 50% throughout the surgery, provided that SpO₂ remained ≥ 98%. Receives: Device: Conventional oxygen administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thiol-disulfide balance.
Plasma native thiol, total thiol, and disulfide levels will be measured. The disulfide-to-thiol ratio will be used as a marker of oxidative stress. Unit of Measure: µmol/L
Measured: preoperative to end of surgery (before awakening)
Change in ischemia-modified albumin (IMA) levels.
Serum IMA levels will be measured as an indicator of oxidative stress. IMA reflects modification of the N-terminal region of albumin by reactive oxygen species (ROS). Unit of Measure: Absorbance Units (ABS units)
Measured: preoperative-end of surgery (before awakening)
Secondary outcomes (1)
PaO₂ levels.
To compare intraoperative PaO₂ changes between ORI and Control groups. Arterial blood gas samples were obtained from all patients after intubation, at the 2nd hour of surgery, and at the end of the procedure before awakening.
Measured: From baseline (after intubation) to end of surgery (before awakening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Mar 2021
- Primary completion20 Aug 2021
- Study completion30 Aug 2021
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 RhinoplastyStudies 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
- Model description
- On the day of surgery, patients were randomly assigned into two groups -ORI group (Group R) and control group (Group C)- using the sealed envelope method. Patients in Group R received ORI monitoring in addition to intraoperative standart monitoring (ECG, pulse oximetry, non-invasive arterial blood pressure). For this purpose, an ORI sensor (RD Rainbow SET sensor, Masimo Corp., Irvine, CA, USA) was placed on the fourth finger of the upper extremity where there was no blood pressure cuff. The sensor was wrapped to prevent exposure to light and connected to an oximeter device (Raical-7® Pulse CO-Oximater®, Masimo Corp., Irvine, CA, USA). Patients in Group C received only standard monitoring.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Recep Karakaşoğlu, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Banu E Çevik, MD, Study director, University of Health Sciences, Kartal Dr. Lütfi Kırdar City HospitalFatih D Geyik, MD, Principal investigator, University of Health Sciences, Kartal Dr. Lütfi Kırdar City HospitalKemal T Saraçoğlu, MD, Principal investigator, University of Health Sciences, Kartal Dr. Lütfi Kırdar City HospitalRecep karakaşoğlu, MD, Principal investigator, University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158073
- Sponsor's protocol ID
- DLKCH-AR-RK-01
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakasoglu R, Geyik FD, Cevik BE, Saracoglu KT. The effect of oxygen reserve index guided oxygen titration on oxidative stress in rhinoplasty surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Nov 4;25(1):542. doi: 10.1186/s12871-025-03424-0.
PubMed 41188744
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxygen Reserve Index Guided Oxygen Titration on Oxidative Stress in Rhinoplasty Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07158073
- Acronym / sponsor ID
- DLKCH-AR-RK-01
- Conditions
- Rhinoplasty, Oxidative Stress, Hyperoxia, Oxygen Reserve Index
- Keywords
- Rhinoplasty surgery, Oxygen Reserve Index, Oxidative Stress, Hyperoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 5 Sep 2025 (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.
The aim of this study is to evaluate whether the use of Oxygen Reserve Index (ORİ) can prevent hyperoxia in patients undergoing rhinoplasty surgery and whether it can reduce oxidative stress caused by hyperoxia.
Detailed description
ORI is a continuous, non-invasive parameter provided by new-generation pulse oximeters utilizing multi-wavelength pulse oximetry technology. ORI serves as an important monitoring tool for detecting both hyperoxemia and desaturation in patients with decreased PaO₂ levels. Studies have demonstrated that ORI provides values within a range of 0 to 1, and an ORI value of 0 corresponds to a PaO₂ level between 80 and 125 mmHg.
Oxygen is commonly used in clinical practice to prevent or treat hypoxia; however, excessive use may lead to oxidative stress. Oxidative stress is defined as a disruption of the oxidative balance resulting from an increased generation of reactive oxygen species (ROS) during cellular metabolism and an insufficient level of antioxidants to detoxify them. ROS are formed by the reaction of molecular oxygen with H₂O, the most stable form of oxygen. In this reaction, the stepwise addition of electrons to molecular oxygen (O₂) leads to the formation of superoxide anion (O₂ˉ), hydrogen peroxide (H₂O₂), and hydroxyl radical (-OH). Among these, the hydroxyl radical is the most reactive form of oxygen radicals.
Although ROS are essential for normal cellular functions such as intracellular signaling and defense against external threats, their excessive production can lead to molecular and cellular dysfunction. Excessive ROS attack nucleotide bases in nucleic acids, amino acid side chains in proteins, and double bonds in unsaturated fatty acids, resulting in oxidative stress that damages DNA, RNA, proteins, and lipids, leading to structural and metabolic changes in cells.
The primary aim of the investigators in this study is to determine whether ORI-guided oxygen titration during rhinoplasty surgery can help prevent hyperoxia and reduce oxidative stress compared with conventional oxygen therapy. To evaluate oxidative stress, thiol-disulfide balance and ischemia-modified albumin (IMA) levels will be assessed in the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- On the day of surgery, patients were randomly assigned into two groups -ORI group (Group R) and control group (Group C)- using the sealed envelope method. Patients in Group R received ORI monitoring in addition to intraoperative standart monitoring (ECG, pulse oximetry, non-invasive arterial blood pressure). For this purpose, an ORI sensor (RD Rainbow SET sensor, Masimo Corp., Irvine, CA, USA) was placed on the fourth finger of the upper extremity where there was no blood pressure cuff. The sensor was wrapped to prevent exposure to light and connected to an oximeter device (Raical-7® Pulse CO-Oximater®, Masimo Corp., Irvine, CA, USA). Patients in Group C received only standard monitoring.
| Arm | Type | Receives |
|---|---|---|
| ORI group (Group R) | Active comparator | Device: FiO₂ titration, under the guidance of ORIPatients in Group R received ORI monitoring in addition to intraoperative standart monitoring (ECG, pulse oximetry, non-invasive arterial blood pressure). For this purpose, an ORI sensor (RD Rainbow SET sensor, Masimo Corp., Irvine, CA, USA) was placed on the fourth finger of the upper extremity where there was no blood pressure cuff. The sensor was wrapped to prevent exposure to light and connected to an oximeter device (Raical-7® Pulse CO-Oximater®, Masimo Corp., Irvine, CA, USA).In Group R, mask ventilation was administered with 50% oxygen. FiO₂ was titrated between 30% and 50% under the guidance of ORI and SpO₂ values. Accordingly, if SpO₂ was ≥ 98%, FiO₂ was reduced in 5% increments to a minimum of 30%, aiming to achieve an ORI value of 0 or as close to 0 as possible. |
| Control group (Group C) | Active comparator | Device: Conventional oxygen administrationPatients in Group C received only standard monitoring. Mask ventilation was administered with 100% oxygen. FiO₂ was maintained at 50% throughout the surgery, provided that SpO₂ remained ≥ 98%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- classified as ASA physical status I or II
Key exclusion criteria (8 listed)
- under 18 years of age
- ASA classification greater than II
- Mallampati score of 3 or 4
- findings suggestive of difficult intubation during physical examination
- any pathological findings on chest X-ray evaluation (e.g., pleural effusion, nodular density increase, emphysema, atelectasis, calcification, mediastinal widening, or infiltration)
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 |
|---|---|---|
| FiO₂ titration, under the guidance of ORIIn Group R, FiO₂ was titrated between 30% and 50% under the guidance of ORI and SpO₂ values. Accordingly, if SpO₂ was ≥ 98%, FiO₂ was reduced in 5% increments to a minimum of 30%, aiming to achieve an ORI value of 0 or as close to 0 as possible. | Device | ORI group (Group R) |
| Conventional oxygen administrationIn Group C, FiO₂ was maintained at 50% throughout the surgery, provided that SpO₂ remained ≥ 98%. | Device | Control group (Group C) |
Primary outcome
Change in thiol-disulfide balance.
Time frame: preoperative to end of surgery (before awakening)
Plasma native thiol, total thiol, and disulfide levels will be measured. The disulfide-to-thiol ratio will be used as a marker of oxidative stress. Unit of Measure: µmol/L
Change in ischemia-modified albumin (IMA) levels.
Time frame: preoperative-end of surgery (before awakening)
Serum IMA levels will be measured as an indicator of oxidative stress. IMA reflects modification of the N-terminal region of albumin by reactive oxygen species (ROS). Unit of Measure: Absorbance Units (ABS units)
1 secondary outcome
PaO₂ levels.
Time frame: From baseline (after intubation) to end of surgery (before awakening)
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 8 Sep 2025.
- Derived from this study: PubMed 41188744Karakasoglu R, Geyik FD, Cevik BE, Saracoglu KT. The effect of oxygen reserve index guided oxygen titration on oxidative stress in rhinoplasty surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Nov 4;25(1):542. doi: 10.1186/s12871-025-03424-0.
- Individual participant dataSharing planned: No
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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.
Banu E Çevik, MD study director
University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
Fatih D Geyik, MD principal investigator
University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
Kemal T Saraçoğlu, MD principal investigator
University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiO₂ titration, under the guidance of ORI and Conventional oxygen administration in people with Rhinoplasty and Oxidative Stress, run by Dr. Lutfi Kirdar Kartal Training and Research 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 8 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 8 Sep 2025. 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?
Change in thiol-disulfide balance. (time frame: preoperative to end of surgery (before awakening)). The study lists 2 primary outcomes in all. 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 NCT07158073, 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 8 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.