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ORI Monitoring in Low and Normal Flow Anesthesia Applications

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Summary

NIH registered an observational clinical study (NCT07538817) on ClinicalTrials.gov investigating Oxygen Reserve Index (ORI) monitoring during laparoscopic nephrectomy. The study compares low and normal fresh gas flow anesthesia approaches to determine optimal oxygenation levels, aiming to prevent both hypoxemia and hyperoxemia in surgical patients.

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What changed

This document registers an observational clinical study on ClinicalTrials.gov. The study examines ORI monitoring to enable optimal oxygen titration during laparoscopic nephrectomy, comparing outcomes under low-flow versus normal-flow anesthesia. This is a registry entry providing research protocol details and does not impose compliance obligations on healthcare providers or manufacturers.

Healthcare institutions conducting or reviewing anesthesia protocols may find the study's findings relevant to perioperative oxygen management practices once results are published, though no immediate action is required based on this registration alone.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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ORI MONITORING IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS

Observational NCT07538817 Kind: OBSERVATIONAL Apr 20, 2026

Abstract

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.

Conditions: HYPEROXY, OXYGEN RESERVE INDEX

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Anesthesia monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Clinical Operations Medical Devices

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