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RECRUITING
NCT07718295
NA

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

Sponsor: Firat University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-06-01

Completion Date

2026-12-31

Last Updated

2026-07-21

Healthy Volunteers

No

Interventions

DEVICE

High-Flow Nasal Oxygen (HFNO)

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

DEVICE

Conventional 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)