- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of view
Lasso di tempo: 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).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cormack-Lehane classification
Lasso di tempo: 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)
Lasso di tempo: 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).
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- HFNORCT
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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