HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

Firat University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

100

Conditions

Procedural Sedation Hypoxemia Cerebral Oxygenation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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.

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts