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HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

16. juli 2026 opdateret af: AHMET AKSU, Firat University

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Elâzığ
      • Elâzığ, Elâzığ, Tyrkiet (Türkiye), 23100
        • Rekruttering
        • Fırat University Faculty of Medicine Hospital
        • Kontakt:
          • Ahmet Aksu, Assistant Professor
          • Telefonnummer: +904242333555 +905303493896
          • E-mail: drahmetaksu@gmail.com
        • Kontakt:
        • Underforsker:
          • Ahmet Demirdağ, Assistant Professor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: High-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Enhed: High-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Aktiv komparator: Conventional Face Mask Oxygen
Participants receive conventional face mask oxygen therapy during procedural sedation.
Enhed: Conventional Face Mask Oxygen
Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
Tidsramme: 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.
From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peripheral Oxygen Saturation (SpO₂)
Tidsramme: From baseline to completion of procedural sedation (up to approximately 120 minutes).
From baseline to completion of procedural sedation (up to approximately 120 minutes).
End-Tidal Carbon Dioxide (EtCO₂)
Tidsramme: Baseline and at completion of the procedure.
Baseline and at completion of the procedure.
Arterial Oxygen Tension (PaO₂)
Tidsramme: Before sedation and immediately after completion of the procedure.
Before sedation and immediately after completion of the procedure.
Arterial Carbon Dioxide Tension (PaCO₂)
Tidsramme: Before sedation and immediately after completion of the procedure.
Before sedation and immediately after completion of the procedure.
Incidence of Hypoxemia
Tidsramme: During procedural sedation (up to approximately 120 minutes).
Peripheral oxygen saturation <90% lasting at least 10 seconds.
During procedural sedation (up to approximately 120 minutes).
Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline
Tidsramme: 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.
During procedural sedation (up to approximately 120 minutes).
Number of Participants Requiring Airway Intervention During Procedural Sedation
Tidsramme: 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.
During procedural sedation.
Patient State Index (PSI) During Procedural Sedation
Tidsramme: 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.
Throughout procedural sedation until completion of the procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation
Tidsramme: 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.
Throughout procedural sedation until completion of the procedure.
Heart Rate During Procedural Sedation
Tidsramme: From baseline until completion of the procedure.
Mean heart rate (beats per minute) recorded from baseline until completion of the procedure.
From baseline until completion of the procedure.
Mean Arterial Pressure During Procedural Sedation
Tidsramme: Throughout procedural sedation until completion of the procedure.
Mean non-invasive arterial blood pressure (mmHg) recorded from baseline until completion of the procedure.
Throughout procedural sedation until completion of the procedure.
Sedative Drug Consumption
Tidsramme: During procedural sedation.
Total doses of propofol, remifentanil, and midazolam.
During procedural sedation.
Patient Satisfaction Score Using a 5-Point Likert Scale
Tidsramme: 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.
Immediately after recovery from procedural sedation.
Practitioner Satisfaction Score Using a 5-Point Likert Scale
Tidsramme: 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.
Immediately after completion of the procedure.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Firat University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 47670

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med High-Flow Nasal Oxygen (HFNO)

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