HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
Recruiting now · Not applicable
Conditions studied: Procedural Sedation, Hypoxemia, Cerebral Oxygenation, SEDLine
In brief
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.
Key facts
- Study ID
- NCT07718295
- Run by
- Firat University
- People needed
- 100
- Starts
- 2026-06-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Fırat University Faculty of Medicine Hospital — Elâzığ, Elâzığ, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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