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HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

NCT07718295 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-21

No results posted yet for this study

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.

Conditions

  • Procedural Sedation
  • Hypoxemia
  • Cerebral Oxygenation
  • SEDLine

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%.

Sponsors & Collaborators

  • Firat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-01
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718295 on ClinicalTrials.gov