Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07718295). StuddyBuddy aggregates publicly available trial information.