ORI MONITORING IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS

April 13, 2026 updated by: Hilal AKCA, Başakşehir Çam & Sakura City Hospital

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.

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Estimated)

48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Ages 18-75, ASA I,II, elective surgery laparoscopic nephrectomy

Description

Inclusion Criteria:

  • Ages 18-75
  • ASA I,II
  • elective surgery laparoscopic nephrectomy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
low-flow anesthesia
0,5 lt/min
normal flow anesthesia
2 lt/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Perioperative period(approximately 3-6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of lateral decubitus position on oxygenation in laparoscopic nephrectomies
Time Frame: Perioperative period(approximately 3-6 hours)
Perioperative period(approximately 3-6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

August 20, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ORI-HT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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