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HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

16. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Elâzığ
      • Elâzığ, Elâzığ, Türkei (türkiye), 23100
        • Rekrutierung
        • Fırat University Faculty of Medicine Hospital
        • Kontakt:
          • Ahmet Aksu, Assistant Professor
          • Telefonnummer: +904242333555 +905303493896
          • E-Mail: drahmetaksu@gmail.com
        • Kontakt:
        • Unterermittler:
          • Ahmet Demirdağ, Assistant Professor

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Gerät: High-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Aktiver Komparator: Conventional Face Mask Oxygen
Participants receive conventional face mask oxygen therapy during procedural sedation.
Gerät: Conventional Face Mask Oxygen
Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peripheral Oxygen Saturation (SpO₂)
Zeitfenster: 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)
Zeitfenster: Baseline and at completion of the procedure.
Baseline and at completion of the procedure.
Arterial Oxygen Tension (PaO₂)
Zeitfenster: Before sedation and immediately after completion of the procedure.
Before sedation and immediately after completion of the procedure.
Arterial Carbon Dioxide Tension (PaCO₂)
Zeitfenster: Before sedation and immediately after completion of the procedure.
Before sedation and immediately after completion of the procedure.
Incidence of Hypoxemia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During procedural sedation.
Total doses of propofol, remifentanil, and midazolam.
During procedural sedation.
Patient Satisfaction Score Using a 5-Point Likert Scale
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Firat University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2026

Zuerst gepostet (Tatsächlich)

21. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 47670

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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