An interventional study of High-Flow Nasal Oxygen (HFNO) and Conventional Face Mask Oxygen in Procedural Sedation, Hypoxemia and Cerebral Oxygenation, sponsored by Firat University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Firat University · Not applicable, Interventional, and Supportive care
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Firat University is the lead sponsor of 117 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Device: High-Flow Nasal Oxygen (HFNO)
Participants receive conventional face mask oxygen therapy during procedural sedation.
Device: Conventional Face Mask Oxygen
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%.
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
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 initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).
Peripheral Oxygen Saturation (SpO₂)
Time frame: From baseline to completion of procedural sedation (up to approximately 120 minutes).
End-Tidal Carbon Dioxide (EtCO₂)
Time frame: Baseline and at completion of the procedure.
Arterial Oxygen Tension (PaO₂)
Time frame: Before sedation and immediately after completion of the procedure.
Arterial Carbon Dioxide Tension (PaCO₂)
Time frame: Before sedation and immediately after completion of the procedure.
Incidence of Hypoxemia
Peripheral oxygen saturation \<90% lasting at least 10 seconds.
Time frame: During procedural sedation (up to approximately 120 minutes).
Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline
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 (up to approximately 120 minutes).
Number of Participants Requiring Airway Intervention 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: During procedural sedation.
Patient State Index (PSI) During Procedural Sedation
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.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation
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: Throughout procedural sedation until completion of the procedure.
Heart Rate During Procedural Sedation
Mean heart rate (beats per minute) recorded from baseline until completion of the procedure.
Time frame: From baseline until completion of the procedure.
Mean Arterial Pressure During Procedural Sedation
Mean non-invasive arterial blood pressure (mmHg) recorded from baseline until completion of the procedure.
Time frame: Throughout procedural sedation until completion of the procedure.
Sedative Drug Consumption
Total doses of propofol, remifentanil, and midazolam.
Time frame: During procedural sedation.
Patient Satisfaction Score Using a 5-Point Likert Scale
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 recovery from procedural sedation.
Practitioner Satisfaction Score Using a 5-Point Likert Scale
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.
Time frame: Immediately after completion of the procedure.
Plan to share: No — Individual participant data (IPD) will not be shared because the study was not designed with a data-sharing plan, and participant-level data contain potentially identifiable information.
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