ORI MONITORING IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS

NCT07538817 | Not Yet Recruiting

• 1 other identifier: ORI-HT
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Early detection of hypoxia and hyperoxia in laparoscopic nephrectomy cases with low and normal flow anesthesia using ORI monitoring.

  Perioperative period(approximately 3-6 hours

Secondary Outcomes (1)

• The effect of lateral decubitus position on oxygenation in laparoscopic nephrectomies

  Perioperative period(approximately 3-6 hours)

Study Arms (2)

low-flow anesthesia

0,5 lt/min

normal flow anesthesia

2 lt/min

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04