HYPEROXYNCT07538817
ORI MONITORING IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS
An observational study of HYPEROXY and OXYGEN RESERVE INDEX, run by Başakşehir Çam & Sakura City Hospital.
Trial summary
Oxygen administration is essential in the perioperative period to prevent hypoxia; however, excessive oxygen may cause hyperoxia and related complications. While pulse oximetry is effective in detecting hypoxemia, it is insufficient for identifying hyperoxia when SpO₂ exceeds 97%, often necessitating invasive arterial… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HYPEROXY, OXYGEN RESERVE INDEX
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ages 18-75, ASA I,II, elective surgery laparoscopic nephrectomy
Who may be able to join
- Ages 18-75
- ASA I,II
- elective surgery laparoscopic nephrectomy
Who cannot join
- ASA III,IV,V
- BMI > 35
- Those with serious respiratory disease
- Medications that cause peripheral circulation disorders
- Patients who started with laparoscopic surgery and then underwent open surgery
About this study
Official title: EVALUATION OF OXYGEN RESERVE INDEX IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS IN LAPAROSCOPIC NEPHRECTOMY CASES IN LATERAL DECUBIT POSITION
Oxygen administration is essential in the perioperative period to prevent hypoxia; however, excessive oxygen may cause hyperoxia and related complications. While pulse oximetry is effective in detecting hypoxemia, it is insufficient for identifying hyperoxia when SpO₂ exceeds 97%, often necessitating invasive arterial blood gas analysis. The Oxygen Reserve Index (ORI) is a noninvasive, real-time monitoring parameter reflecting moderate hyperoxic ranges (PaO₂ 100-200 mmHg) and provides early warning of oxygenation changes before SpO₂ alterations occur. Combined use of ORI and pulse oximetry may enable optimal oxygen titration and prevention of both hypoxemia and hyperoxemia.
Laparoscopic nephrectomy is widely performed due to its clinical advantages. In our practice, low and normal fresh gas flow anesthesia are commonly used. Low-flow anesthesia offers benefits such as preservation of heat and humidity, reduced cost, and improved airway physiology. This study aims to determine optimal oxygenation levels during laparoscopic nephrectomy under low and normal fresh gas flow conditions using ORI monitoring.
Read the detailed description
Oxygen is routinely administered to patients in the perioperative setting to prevent the harmful effects of hypoxia. However, high oxygen concentrations may lead to hyperoxia, which can result in significant complications. Therefore, early detection of both hypoxemia and hyperoxemia during the perioperative period is crucial. Pulse oximetry is highly effective in detecting hypoxemia; however, it is insufficient for evaluating oxygenation when SpO₂ exceeds 97%, limiting its usefulness in identifying hyperoxia. In such cases, arterial blood gas analysis, an invasive method, is typically required.
The Oxygen Reserve Index (ORI) is a noninvasive, real-time, and continuous monitoring parameter used to assess oxygenation status. ORI values range from 0 to 1 and reflect arterial partial oxygen pressure levels between approximately 100 and 200 mmHg. Importantly, ORI provides an early warning of deteriorating oxygenation before any detectable changes occur in SpO₂. The combined use of ORI and pulse oximetry may facilitate more precise titration of inspired oxygen concentration and help prevent both hypoxemia and hyperoxemia.
Laparoscopic surgery offers several advantages, including reduced blood loss, improved wound healing, decreased postoperative pain, and shorter hospital stays. Accordingly, laparoscopic techniques are frequently employed for nephrectomy procedures in our clinic.
Depending on clinician preference, low, normal, and high fresh gas flow rates are commonly and safely used in our practice. Low-flow anesthesia provides benefits such as preservation of heat and humidity within the respiratory system, reduced costs, and decreased environmental pollution. Additionally, improved preservation of mucociliary clearance contributes to better maintenance of airway physiology.
In high-risk and major surgeries such as laparoscopic nephrectomy, ORI monitoring is routinely utilized in our clinic to minimize the risks of hypoxemia and hyperoxemia. In this study, we aim to determine optimal oxygenation levels during laparoscopic nephrectomy procedures performed under low and normal fresh gas flow conditions.
- Conditions
- HYPEROXY, OXYGEN RESERVE INDEX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low-flow anesthesia | 0,5 lt/min | |
| normal flow anesthesia | 2 lt/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of hypoxia and hyperoxia in laparoscopic nephrectomy cases with low and normal flow anesthesia using ORI monitoring.
Measured: Perioperative period(approximately 3-6 hours
Secondary outcomes (1)
The effect of lateral decubitus position on oxygenation in laparoscopic nephrectomies
Measured: Perioperative period(approximately 3-6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HYPEROXYStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilal AKCA, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538817
- Sponsor's protocol ID
- ORI-HT
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF OXYGEN RESERVE INDEX IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS IN LAPAROSCOPIC NEPHRECTOMY CASES IN LATERAL DECUBIT POSITION
- ClinicalTrials.gov ID
- NCT07538817
- Acronym / sponsor ID
- ORI-HT
- Conditions
- HYPEROXY, OXYGEN RESERVE INDEX
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 20 Apr 2026 (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.
Oxygen administration is essential in the perioperative period to prevent hypoxia; however, excessive oxygen may cause hyperoxia and related complications. While pulse oximetry is effective in detecting hypoxemia, it is insufficient for identifying hyperoxia when SpO₂ exceeds 97%, often necessitating invasive arterial blood gas analysis. The Oxygen Reserve Index (ORI) is a noninvasive, real-time monitoring parameter reflecting moderate hyperoxic ranges (PaO₂ 100-200 mmHg) and provides early warning of oxygenation changes before SpO₂ alterations occur. Combined use of ORI and pulse oximetry may enable optimal oxygen titration and prevention of both hypoxemia and hyperoxemia.
Laparoscopic nephrectomy is widely performed due to its clinical advantages. In our practice, low and normal fresh gas flow anesthesia are commonly used. Low-flow anesthesia offers benefits such as preservation of heat and humidity, reduced cost, and improved airway physiology. This study aims to determine optimal oxygenation levels during laparoscopic nephrectomy under low and normal fresh gas flow conditions using ORI monitoring.
Detailed description
Oxygen is routinely administered to patients in the perioperative setting to prevent the harmful effects of hypoxia. However, high oxygen concentrations may lead to hyperoxia, which can result in significant complications. Therefore, early detection of both hypoxemia and hyperoxemia during the perioperative period is crucial. Pulse oximetry is highly effective in detecting hypoxemia; however, it is insufficient for evaluating oxygenation when SpO₂ exceeds 97%, limiting its usefulness in identifying hyperoxia. In such cases, arterial blood gas analysis, an invasive method, is typically required.
The Oxygen Reserve Index (ORI) is a noninvasive, real-time, and continuous monitoring parameter used to assess oxygenation status. ORI values range from 0 to 1 and reflect arterial partial oxygen pressure levels between approximately 100 and 200 mmHg. Importantly, ORI provides an early warning of deteriorating oxygenation before any detectable changes occur in SpO₂. The combined use of ORI and pulse oximetry may facilitate more precise titration of inspired oxygen concentration and help prevent both hypoxemia and hyperoxemia.
Laparoscopic surgery offers several advantages, including reduced blood loss, improved wound healing, decreased postoperative pain, and shorter hospital stays. Accordingly, laparoscopic techniques are frequently employed for nephrectomy procedures in our clinic.
Depending on clinician preference, low, normal, and high fresh gas flow rates are commonly and safely used in our practice. Low-flow anesthesia provides benefits such as preservation of heat and humidity within the respiratory system, reduced costs, and decreased environmental pollution. Additionally, improved preservation of mucociliary clearance contributes to better maintenance of airway physiology.
In high-risk and major surgeries such as laparoscopic nephrectomy, ORI monitoring is routinely utilized in our clinic to minimize the risks of hypoxemia and hyperoxemia. In this study, we aim to determine optimal oxygenation levels during laparoscopic nephrectomy procedures performed under low and normal fresh gas flow conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-flow anesthesia | – | –0,5 lt/min |
| normal flow anesthesia | – | –2 lt/min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ages 18-75, ASA I,II, elective surgery laparoscopic nephrectomy
Key inclusion criteria (3 listed)
- Ages 18-75
- ASA I,II
- elective surgery laparoscopic nephrectomy
Key exclusion criteria (5 listed)
- ASA III,IV,V
- BMI > 35
- Those with serious respiratory disease
- Medications that cause peripheral circulation disorders
- Patients who started with laparoscopic surgery and then underwent open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early detection of hypoxia and hyperoxia in laparoscopic nephrectomy cases with low and normal flow anesthesia using ORI monitoring.
Time frame: Perioperative period(approximately 3-6 hours
1 secondary outcome
The effect of lateral decubitus position on oxygenation in laparoscopic nephrectomies
Time frame: Perioperative period(approximately 3-6 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HYPEROXY and OXYGEN RESERVE INDEX, run by Başakşehir Çam & Sakura City Hospital.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Early detection of hypoxia and hyperoxia in laparoscopic nephrectomy cases with low and normal flow anesthesia using ORI monitoring. (time frame: Perioperative period(approximately 3-6 hours). 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 20 Apr 2026.