RecruitingNot ApplicableNCT07718295

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial


Sponsor

Firat University

Enrollment

100 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Conventional Face Mask Oxygen and a medical device called High-Flow Nasal Oxygen (HFNO) for people with cerebral oxygenation, hypoxemia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-Flow Nasal Oxygen (HFNO)

Participants receive heated humidified high-flow nasal oxygen during procedural sedation.

DEVICEConventional Face Mask Oxygen

Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.


Locations(1)

Fırat University Faculty of Medicine Hospital

Elâzığ, Elâzığ, Turkey (Türkiye)

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NCT07718295


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