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Recruiting NCT07718295

HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

No phase Interventional Procedural Sedation Hypoxemia Cerebral Oxygenation SEDLine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Flow Nasal Oxygen (HFNO), Conventional Face Mask Oxygen.
Who it may be relevant to
Registry conditions: Procedural Sedation, Hypoxemia, Cerebral Oxygenation, SEDLine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Device High-Flow Nasal Oxygen (HFNO)
    Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
  • Device Conventional Face Mask Oxygen
    Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.

Primary outcome measures

  • Change in Regional Cerebral Oxygen Saturation (ΔrSO₂) [Time frame: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).]
Secondary outcome measures (12)
  • 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 [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 [Time frame: During procedural sedation (up to approximately 120 minutes).]
  • Number of Participants Requiring Airway Intervention During Procedural Sedation [Time frame: During procedural sedation.]
  • Patient State Index (PSI) During Procedural Sedation [Time frame: Throughout procedural sedation until completion of the procedure.]
  • Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation [Time frame: Throughout procedural sedation until completion of the procedure.]
  • Heart Rate During Procedural Sedation [Time frame: From baseline until completion of the procedure.]
  • Mean Arterial Pressure During Procedural Sedation [Time frame: Throughout procedural sedation until completion of the procedure.]
  • Sedative Drug Consumption [Time frame: During procedural sedation.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Fırat University Faculty of Medicine Hospital — Elâzığ

Identifiers

NCT: NCT07718295 · 47670

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗