NCT Number: NCT07718295
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Elâzığ, 23100, Turkey (Türkiye)
Location status: Recruiting
Ahmet Aksu, Assistant Professor
CONTACT
+905303493896 ext. +904242333555
Ahmet Demirdağ, Assistant Professor
CONTACT
Ahmet Demirdağ, Assistant Professor
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.
Time frame: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).
The change in regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS), calculated as the difference between the mean intra-procedural rSO₂ and the baseline value.
Time frame: From baseline to completion of procedural sedation (up to approximately 120 minutes).
Time frame: Baseline and at completion of the procedure.
Time frame: Before sedation and immediately after completion of the procedure.
Time frame: Before sedation and immediately after completion of the procedure.
Time frame: During procedural sedation (up to approximately 120 minutes).
Peripheral oxygen saturation <90% lasting at least 10 seconds.
Time frame: During procedural sedation (up to approximately 120 minutes).
Number of participants who experience a decrease in regional cerebral oxygen saturation (rSO₂) of 20% or more from the baseline value during procedural sedation.
Time frame: During procedural sedation.
Number of participants requiring any airway intervention, including chin lift, jaw thrust, mask ventilation, supraglottic airway placement, or endotracheal intubation during procedural sedation.
Time frame: Throughout procedural sedation until completion of the procedure.
Mean Patient State Index (PSI) recorded throughout procedural sedation. The PSI ranges from 0 to 100, with lower values indicating deeper levels of sedation.
Time frame: Throughout procedural sedation until completion of the procedure.
Mean Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score recorded during procedural sedation. Scores range from 0 to 5, where lower scores indicate deeper sedation and higher scores indicate greater alertness.
Time frame: From baseline until completion of the procedure.
Mean heart rate (beats per minute) recorded from baseline until completion of the procedure.
Time frame: Throughout procedural sedation until completion of the procedure.
Mean non-invasive arterial blood pressure (mmHg) recorded from baseline until completion of the procedure.
Time frame: During procedural sedation.
Total doses of propofol, remifentanil, and midazolam.
Time frame: Immediately after recovery from procedural sedation.
Patient satisfaction was assessed immediately after recovery using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Time frame: Immediately after completion of the procedure.
Practitioner satisfaction with the procedure was assessed immediately after completion using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Contact information is provided by the study sponsor or research team.
Firat University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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