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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
Timeframe: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).