- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07575776
Effect of High-Flow Nasal Oxygen on Laryngoscopic View
Effect of Different Flows Using High-Flow Nasal Oxygen (HFNO) on Laryngoscopic View Quality During Videolaryngoscopy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Anaesthetic management Anaesthesia induction and airway management will be standardized as far as clinically feasible. Standard monitoring will be applied according to institutional practice. Preoxygenation will be performed using high-flow nasal oxygen (HFNO). General anaesthesia will be induced using standard intravenous agents, followed by administration of neuromuscular blockade to facilitate laryngoscopy. Mask ventilation will be performed as clinically indicated.
Videolaryngoscopy will be performed using a standardized device and blade type whenever possible. All procedures will be performed by anesthesiologists experienced in videolaryngoscopy.
Study procedure
After induction of anaesthesia and achievement of adequate conditions for laryngoscopy, videolaryngoscopy will be performed. During a single laryngoscopic sequence, images of the laryngeal view will be obtained under three predefined HFNO flow conditions:
- 0 L/min
- 40 L/min
- 60 L/min At each flow level, once a stable laryngeal view will be achieved, a still image will be captured using the videolaryngoscope recording system. The laryngoscope position will be maintained as stable as possible during acquisition of all three images. No attempt at tracheal intubation will be made during image acquisition.
After completion of the image capture protocol, tracheal intubation will be performed according to standard clinical practice.
All images will be anonymized and stored for subsequent offline analysis. Image assessment Captured images will be evaluated offline by an independent anesthesiologist blinded to HFNO flow rates and patient identity. Where applicable, evaluation will be performed by more than one assessor to allow assessment of inter-rater agreement.
Each image will be assessed using predefined objective and subjective measures (Percentage of Glottic Opening, Likert scale).
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age ≥18 years
- Scheduled for endotracheal intubation under general anesthesia
- Use of videolaryngoscopy
Exclusion Criteria:
- Anticipated difficult airway
- Emergency intubation
- Contraindications to HFNO
- Inability to obtain adequate video recording
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Group HFNO
Adult patients with HFNO support for airway management
|
Different flows will be applied to patients undergoing general anaesthesia during airway management.
In this arm flow will be 0 l/min.
During these flows images will be captured using videolaryngoscope.
Different flows will be applied to patients undergoing general anaesthesia during airway management.
In this arm flow will 40 l/min.
During these flows images will be captured using videolaryngoscope.
Different flows will be applied to patients undergoing general anaesthesia during airway management.
In this arm flow will 60 l/min.
During these flows images will be captured using videolaryngoscope.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of view
Délai: From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Percentage of glottic opening (POGO score) assessed from recorded videolaryngoscopic images.
|
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cormack-Lehane classification
Délai: From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Ordinal grading of glottic view using Cormack- Lehane classification.
|
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
|
Subjective image quality (Likert scale)
Délai: From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Subjective assessment of laryngoscopic image quality rated on a 5-point Likert scale (1 = very poor, 5 = excellent) by independent evaluators blinded to HFNO flow conditions
|
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HFNORCT
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .