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HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

ConditionsProcedural SedationHypoxemiaCerebral OxygenationSEDLine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirat University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age younger than 18 years

Refusal or inability to provide written informed consent

Known neurological disorders

History of ischemic or hemorrhagic stroke

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Flow Nasal Oxygen (HFNO)

    Device

    Participants receive heated humidified high-flow nasal oxygen during procedural sedation.

  • Conventional Face Mask Oxygen

    Device

    Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: High-Flow Nasal Oxygen (HFNO)Experimental treatment 1 intervention
Group B: Conventional Face Mask OxygenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Peripheral Oxygen Saturation (SpO₂)

Time frame
From baseline to completion of procedural sedation (up to approximately 120 minutes).
2

End-Tidal Carbon Dioxide (EtCO₂)

Time frame
Baseline and at completion of the procedure.
3

Arterial Oxygen Tension (PaO₂)

Time frame
Before sedation and immediately after completion of the procedure.
4

Arterial Carbon Dioxide Tension (PaCO₂)

Time frame
Before sedation and immediately after completion of the procedure.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Firat University

Lead sponsor

Source ClinicalTrials.gov
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