HFNO vs. face mask for cerebral oxygenation during procedural sedation
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
Run by Firat University · NCT07718295 · Data updated 2026-11-12
This randomized trial tests whether high-flow nasal oxygen helps maintain brain oxygenation better than a standard face mask during procedures done with sedation in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Firat University Academic / other |
| Locations | 1 site (Elâzığ, Elâzığ) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | December 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT07718295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing elective procedures with procedural sedation in non-OR settings, without conditions that preclude HFNO or NIRS monitoring and who can consent.
✕Probably not a fit
Patients with contraindications to HFNO or NIRS sensors, or those with conditions causing limited brain oxygenation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized study compares high-flow nasal oxygen to conventional face mask oxygen during procedural sedation outside the operating room. Adult participants undergoing elective diagnostic or interventional procedures will be randomly assigned to one of the two oxygen delivery methods. Cerebral oxygenation will be monitored continuously with near-infrared spectroscopy, while sedation depth is tracked using the Patient State Index and MOAA/S scales. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gases, airway interventions, hemodynamics, and user satisfaction from patients and practitioners.
Why it matters
Potential benefit: If successful, HFNO could better preserve brain oxygenation during procedural sedation, potentially reducing hypoxemia or sedation-related events.
How similar studies have gone: Prior research in related settings has suggested HFNO can improve oxygenation, but evidence specifically for cerebral oxygenation during procedural sedation remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * American Society of Anesthesiologists physical status I-IV * Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting * Ability to provide written informed consent * Willingness to participate in the study Exclusion Criteria: * Age younger than 18 years * Refusal or inability to provide written informed consent * Known neurological disorders * History of ischemic or hemorrhagic stroke * History of traumatic brain injury or previous cranial surgery * Peripheral arterial disease or systemic vasculitis * Advanced heart failure * Uncontrolled hypertension * Uncontrolled diabetes mellitus * Advanced chronic obstructive pulmonary disease (COPD) * Severe anemia (hemoglobin \<8 g/dL) * Skin lesions or other conditions preventing proper placement of NIRS sensors * Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy * Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results
Where it's running
-
Fırat University Faculty of Medicine Hospital
Elâzığ, Elâzığ, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ahmet Aksu, Assistant Professor
- Email: drahmetaksu@gmail.com
- Phone: +905303493896
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.