HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirat University
About this trial
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
Qualifiers
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
Disqualifiers
Age younger than 18 years
Refusal or inability to provide written informed consent
Known neurological disorders
History of ischemic or hemorrhagic stroke
Trial design
Treatments tested in this trial
- High-Flow Nasal Oxygen (HFNO)
- Conventional Face Mask Oxygen
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov