HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy
1 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ahmet Aksu, Assistant Professor
- Numéro de téléphone: +905303493896
- E-mail: drahmetaksu@gmail.com
Lieux d'étude
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Elaziğ
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Elâzığ, Elaziğ, Turquie (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
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Contact:
- Ahmet Aksu, Assistant Professor
- Numéro de téléphone: 05303493896
- E-mail: drahmetaksu@gmail.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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|
Expérimental: 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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Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Regional Cerebral Oxygen Saturation (rSO₂)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peripheral Oxygen Saturation (SpO₂)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 septembre 2026
Achèvement de l'étude (Estimé)
1 octobre 2026
Dates d'inscription aux études
Première soumission
22 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
5 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 47669
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .