Cerebral Hypoxia Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Fırat University Faculty of Medicine Hospital
RECRUITING
Elâzığ
Contact Information
Primary
Ahmet Aksu, Assistant Professor
drahmetaksu@gmail.com
+905303493896
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: High-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Active_comparator: Conventional Face Mask Oxygen
Participants receive conventional face mask oxygen therapy during procedural sedation.
Related Therapeutic Areas
Sponsors
Leads: Firat University

This content was sourced from clinicaltrials.gov