HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation | NCT07718295

NCT07718295

Overview

NCT ID: NCT07718295
Lead Sponsor: Firat UniversityOTHER
Official Title: Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial
Brief 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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 <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

Central Contacts: Ahmet Aksu, Assistant ProfessorContact
drahmetaksu@gmail.com+905303493896