Conventional Face Mask Oxygen: Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂) — From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes). The change in regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS), calculated as the difference between the mean intra-procedural rSO₂ and the baseline value.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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