- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02679027
Difficult Intubation and Tongue Protrusion
New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements
Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.
Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.
To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Exclusion Criteria:
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Easy intubation
Intubation difficulty score <5
|
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height).
Patients were asked to protrude tongue maximally and upward (PTMU).
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height).
Patients were asked to protrude tongue maximally and downward (PTMD).
|
|
Comparador activo: Difficult intubation
Intubation difficulty score >5
|
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height).
Patients were asked to protrude tongue maximally and upward (PTMU).
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height).
Patients were asked to protrude tongue maximally and downward (PTMD).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intubation difficulty scale
Periodo de tiempo: 2 days
|
Intubation difficulty scale score includes 7 variables for difficult intubation.
N1: The number of attempts for intubation (for the first attempt 0 point, for the other attempts 1 point each); N2: The number of anesthesiologist for the laryngoscopies (for the first attempt 0 point, for the other attempts 1 point each); N3: Alternative intubation techniques that are used (if not needed 0 point, change of blade type or using blind nasotracheal intubation 1 point each); N4: 1 point less than Cormack and Lehane Classification for defining glottic exposure; N5: The degree of force of lifting laryngoscopy (normal lifting 0 point, more force needed 1 point); N6: Using external laryngeal pressure 1 point; N7: The view of the vocal cords (abduction position 0 point, adduction position 1 point).
A score of 0-4 defines easy intubation and an IDS score ≥5 defines difficult intubation
|
2 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- tongueintubation
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