HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy
1 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ahmet Aksu, Assistant Professor
- Número de teléfono: +905303493896
- Correo electrónico: drahmetaksu@gmail.com
Ubicaciones de estudio
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Elaziğ
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Elâzığ, Elaziğ, Turquía (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
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Contacto:
- Ahmet Aksu, Assistant Professor
- Número de teléfono: 05303493896
- Correo electrónico: drahmetaksu@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: HF40
Participants receive high-flow nasal oxygen (HFNO) therapy at a flow rate of 40 L/min during procedural sedation for cystoscopy.
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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.
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Experimental: HF55
Participants receive HFNO therapy at a flow rate of 55 L/min during procedural sedation for cystoscopy.
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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.
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Experimental: HF70
Participants receive HFNO therapy at a flow rate of 70 L/min during procedural sedation for cystoscopy.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Regional Cerebral Oxygen Saturation (rSO₂)
Periodo de tiempo: 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.
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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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peripheral Oxygen Saturation (SpO₂)
Periodo de tiempo: 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.
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Unit: % .
Evaluation of peripheral oxygenation levels during procedural sedation.
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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.
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Partial arterial carbon dioxide pressure (PaCO₂)
Periodo de tiempo: 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.
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Unit: mmHg.
Assessment of arterial carbon dioxide pressure levels during sedation.
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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.
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End-tidal carbon dioxide (EtCO₂)
Periodo de tiempo: 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.
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Unit: mmHg.
Assessment of end-tidal carbon dioxide levels during sedation.
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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.
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Incidence of Hypoxemia
Periodo de tiempo: 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.
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Frequency of hypoxemia episodes defined as SpO₂ <90% or >20% decrease in rSO₂ from baseline.
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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.
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Airway Intervention Requirement
Periodo de tiempo: 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.
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Need for airway maneuvers or ventilatory support during the procedure.
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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.
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Heart Rate
Periodo de tiempo: From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period.
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Unit: beats/min.
Changes in heart rate during procedural sedation.
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From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period.
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Mean Arterial Pressure
Periodo de tiempo: From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period.
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Unit: mmHg.
Changes in blood pressure during procedural sedation.
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From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period.
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Patient State Index (PSI)
Periodo de tiempo: From the initiation of sedation until the end of the cystoscopy procedure.
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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.
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From the initiation of sedation until the end of the cystoscopy procedure.
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Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
Periodo de tiempo: From the initiation of sedation until the end of the cystoscopy procedure.
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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.
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From the initiation of sedation until the end of the cystoscopy procedure.
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Patient Satisfaction
Periodo de tiempo: 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).
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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.
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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).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 47669
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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