Cerebral Oxygenation, Hypoxemia, Procedural Sedation, SEDLine
Conditions
Keywords
High-flow nasal oxygen (HFNO), Procedural sedation, Cerebral oxygenation, Near-infrared spectroscopy (NIRS), Patient State Index (PSI)
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.
Interventions
DEVICEHigh-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
DEVICEConventional Face Mask Oxygen
Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.
Sponsors
Firat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to receive either high-flow nasal oxygen (HFNO) or conventional face mask oxygen therapy during procedural sedation performed outside the operating room. Both groups will undergo the same standardized sedation protocol, monitoring, and perioperative management, differing only in the oxygen delivery method. Outcomes will be compared between the two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Regional Cerebral Oxygen Saturation (ΔrSO₂) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Oxygen Saturation (SpO₂) | From baseline to completion of procedural sedation (up to approximately 120 minutes). | — |
| End-Tidal Carbon Dioxide (EtCO₂) | Baseline and at completion of the procedure. | — |
| Arterial Oxygen Tension (PaO₂) | Before sedation and immediately after completion of the procedure. | — |
| Arterial Carbon Dioxide Tension (PaCO₂) | Before sedation and immediately after completion of the procedure. | — |
| Incidence of Hypoxemia | During procedural sedation (up to approximately 120 minutes). | Peripheral oxygen saturation \<90% lasting at least 10 seconds. |
| Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline | 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. |
| Number of Participants Requiring Airway Intervention During Procedural Sedation | 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. |
| Patient State Index (PSI) During Procedural Sedation | 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. |
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation | 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. |
| Heart Rate During Procedural Sedation | From baseline until completion of the procedure. | Mean heart rate (beats per minute) recorded from baseline until completion of the procedure. |
| Mean Arterial Pressure During Procedural Sedation | Throughout procedural sedation until completion of the procedure. | Mean non-invasive arterial blood pressure (mmHg) recorded from baseline until completion of the procedure. |
| Sedative Drug Consumption | During procedural sedation. | Total doses of propofol, remifentanil, and midazolam. |
| Patient Satisfaction Score Using a 5-Point Likert Scale | 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. |
| Practitioner Satisfaction Score Using a 5-Point Likert Scale | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAhmet Aksu, Assistant Professor
Outcome results
None listed