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HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy

1. juni 2026 oppdatert av: AHMET AKSU, Firat University

Effect of Different Flow Rates of High-Flow Nasal Oxygen on Peripheral and Cerebral Oxygenation and Ventilation During Procedural Sedation for Cystoscopy: A Prospective Randomized Controlled Trial

For Patients and Families

This study aims to investigate how high-flow oxygen therapy affects oxygen levels, especially brain oxygenation, during cystoscopy procedures performed under sedation. The goal is to improve patient safety and comfort by ensuring better oxygen delivery during the procedure. Different oxygen flow rates will be compared, while patients' breathing, oxygen levels, and vital signs are continuously monitored throughout the procedure. All methods used in the study are consistent with routine anesthesia practices, and patient safety remains the highest priority.

For Healthcare Professionals

This prospective randomized controlled study evaluates the effects of different high-flow nasal oxygen (HFNO) flow rates on cerebral oxygenation, peripheral oxygenation, and ventilation parameters in patients undergoing cystoscopy under procedural sedation. The primary aim is to determine the contribution of HFNO to sedation safety and to provide clinical evidence regarding the optimal flow rate. In addition, hypoxemia incidence, airway intervention requirements, hemodynamic variables, and sedation depth are being analyzed.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Elaziğ
      • Elâzığ, Elaziğ, Tyrkia (Türkiye), 23100
        • Fırat University Faculty of Medicine Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Age ≥18 years
  • Scheduled to undergo elective cystoscopy under procedural sedation in an operating room setting
  • American Society of Anesthesiologists (ASA) physical status classification I-III
  • Ability to provide written informed consent

Exclusion Criteria:

  • Known neurological disorders
  • History of ischemic or hemorrhagic stroke
  • Peripheral artery disease
  • Vasculitis
  • Severe heart failure
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Advanced-stage chronic obstructive pulmonary disease
  • Severe anemia (hemoglobin <8 g/dL)
  • Skin lesions that could interfere with near-infrared spectroscopy (NIRS) measurements
  • History of head trauma
  • History of cranial surgery
  • Nasal deformity or nasal obstruction

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: HF40
Participants receive high-flow nasal oxygen (HFNO) therapy at a flow rate of 40 L/min during procedural sedation for cystoscopy.
Enhet: High-Flow Nasal Oxygen 40 L/min (HF40)
Participants receive high-flow nasal oxygen (HFNO) therapy delivered through the OptiFlow™ system at a flow rate of 40 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy. Sedation is achieved using midazolam, remifentanil, and propofol.
Eksperimentell: HF55
Participants receive HFNO therapy at a flow rate of 55 L/min during procedural sedation for cystoscopy.
Enhet: High-Flow Nasal Oxygen 55 L/min (HF55)
Participants receive HFNO therapy via the OptiFlow™ system at a flow rate of 55 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy, together with the same standardized sedation protocol.
Eksperimentell: HF70
Participants receive HFNO therapy at a flow rate of 70 L/min during procedural sedation for cystoscopy.
Enhet: High-Flow Nasal Oxygen 70 L/min (HF70)
Participants receive HFNO therapy via the OptiFlow™ system at a flow rate of 70 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy, together with the same standardized sedation protocol.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Regional Cerebral Oxygen Saturation (rSO₂)
Tidsramme: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Unit: %. Regional cerebral oxygen saturation values measured by near-infrared spectroscopy (NIRS) during procedural sedation will be compared among the three HFNO flow rate groups to evaluate the effect of different HFNO flow rates on cerebral oxygenation.
From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peripheral Oxygen Saturation (SpO₂)
Tidsramme: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Unit: % . Evaluation of peripheral oxygenation levels during procedural sedation.
From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Partial arterial carbon dioxide pressure (PaCO₂)
Tidsramme: At baseline before the initiation of sedation and at the end of the cystoscopy procedure. Arterial blood gas analysis (PaCO₂) and end-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
Unit: mmHg. Assessment of arterial carbon dioxide pressure levels during sedation.
At baseline before the initiation of sedation and at the end of the cystoscopy procedure. Arterial blood gas analysis (PaCO₂) and end-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
End-tidal carbon dioxide (EtCO₂)
Tidsramme: At baseline before the initiation of sedation and at the end of the cystoscopy procedure. End-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
Unit: mmHg. Assessment of end-tidal carbon dioxide levels during sedation.
At baseline before the initiation of sedation and at the end of the cystoscopy procedure. End-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
Incidence of Hypoxemia
Tidsramme: From the initiation of procedural sedation until the end of the cystoscopy procedure. Hypoxemia episodes occurring during the intraoperative sedation period will be recorded continuously.
Frequency of hypoxemia episodes defined as SpO₂ <90% or >20% decrease in rSO₂ from baseline.
From the initiation of procedural sedation until the end of the cystoscopy procedure. Hypoxemia episodes occurring during the intraoperative sedation period will be recorded continuously.
Airway Intervention Requirement
Tidsramme: From the initiation of procedural sedation until the end of the cystoscopy procedure. Any airway intervention requirement occurring during the intraoperative period will be recorded.
Need for airway maneuvers or ventilatory support during the procedure.
From the initiation of procedural sedation until the end of the cystoscopy procedure. Any airway intervention requirement occurring during the intraoperative period will be recorded.
Heart Rate
Tidsramme: From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period.
Unit: beats/min. Changes in heart rate during procedural sedation.
From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period.
Mean Arterial Pressure
Tidsramme: From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period.
Unit: mmHg. Changes in blood pressure during procedural sedation.
From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period.
Patient State Index (PSI)
Tidsramme: From the initiation of sedation until the end of the cystoscopy procedure.
Unit of Measure: score. Sedation depth will be continuously monitored intraoperatively using Patient State Index (PSI), a numerical electroencephalography-derived index ranging from 0 to 100, where lower values indicate deeper levels of sedation.
From the initiation of sedation until the end of the cystoscopy procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
Tidsramme: From the initiation of sedation until the end of the cystoscopy procedure.
Unit of Measure: score. Sedation depth will be assessed intraoperatively using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, an ordinal sedation scale ranging from 0 to 5, where lower scores indicate deeper levels of sedation.
From the initiation of sedation until the end of the cystoscopy procedure.
Patient Satisfaction
Tidsramme: Assessed once at the end of the recovery period immediately after completion of the cystoscopy procedure (postoperative period, approximately 30-60 minutes after the procedure).
Postoperative patient satisfaction following cystoscopy under procedural sedation will be assessed using a 5-point Likert satisfaction scale, where higher scores indicate greater patient satisfaction.
Assessed once at the end of the recovery period immediately after completion of the cystoscopy procedure (postoperative period, approximately 30-60 minutes after the procedure).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Firat University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. oktober 2026

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 47669

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be publicly shared due to patient confidentiality, privacy concerns, and institutional ethical regulations. Data may be made available from the corresponding author upon reasonable request and with ethics committee approval

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Nei

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