- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01655459
Evaluation of the LMA Position Using Ultrasound in Pediatric Patients
Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA position, but the rotated degree of LMA was not considered in that grading. We hypothesized that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be detected on ultrasound. This study was designed to assess the predictability of the rotated LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.
Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to this study. Ultrasound was performed on supraglottic and vocal cords area before and after LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre- and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of rotation were measured.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Aged 1 ms - 6 years,
- undergoing infraumbilical surgery
Exclusion Criteria:
- coagulopathy
- pathologic lesions on neck or upper airway
- mallampati class III or IV
- difficult airway past history
- high risk group of aspiration pneumonitis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Ultrasound exam of upper airway
Following Internal Review Board approval(4-2011-0800) and written informed consent, total 100 patients(ASA I and II children aged 1 month to 6years) undergoing infra-umblicular urologic surgeries were included in the study.
Children with upper respiratory tract infection, restricted mouth opening, congenital heart disease and those at risk for aspiration were excluded.
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LMA-position was evaluated with fiberoptic laryngoscopy.
The ultrasound findings of pre- and post-LMA were compared.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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changes of Ultrasound image of upper airway after Fiberoptic bronchoscopic grade of LMA insertion.
Periodo de tiempo: After the induction of general anesthesia, ultasound image was gained before and after the LMA insertion. Fiberoptic bronchoscpy was done after the LMA insertion.
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After the induction of general anesthesia, ultasound image was gained before and after the LMA insertion. Fiberoptic bronchoscpy was done after the LMA insertion.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 4-2011-0800
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