- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of view
Prazo: 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cormack-Lehane classification
Prazo: 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)
Prazo: 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).
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- HFNORCT
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .