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NCT07718295
HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
Conditions: Procedural Sedation, Hypoxemia, Cerebral Oxygenation, SEDLine
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Firat University
Location: Fırat University Faculty of Medicine Hospital Elâzığ Elâzığ
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 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 \
Source: ClinicalTrials.gov (NCT07718295). StuddyBuddy aggregates publicly available trial information.