Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients
10 de febrero de 2016 actualizado por: Aylin Ozdilek, Istanbul University
Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Turkish Patients: A Prospective Clinical Trial
The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Patients' Mallampati score, upper lip bite test, neck mobility, teeth abnormalities were evaluated preoperatively. Mouth opening, sternomental and thyromental distances, neck circumference, thoracic circumference, breast circumference , belly circumference and hip circumference were measured preoperatively.
After anesthesia induciton with propofol and rocuronium, patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Laringoscopy was performed with MacIntosh laryngoscop and Cormack Lehane (CL) score was evaluated. CL score III and IV were defined as difficult laryngoscopy.
Tipo de estudio
De observación
Inscripción (Actual)
120
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Istanbul, Pavo, 34098
- Istanbul University Cerrahpasa Medical Faculty
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with body mass index (BMI) > = 40, applied for elective surgery.
Descripción
Inclusion Criteria:
- BMI >= 40
- American Society of Anesthesiologists (ASA) Physical Status I-III
- Patients applied for elective surgery
Exclusion Criteria:
- BMI < 40
- maxillofacial tumor or fracture
- mass at the neck
- mass in the thorax or mediastina
- scar at the neck area
- previous radiotherapy history to neck area
- history of cervical vertebra operations
- cervical vertebra structure abnormality
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation of difficult laryngoscopy with neck circumference
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with neck circumference
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation of difficult laryngoscopy with modified mallampati score
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with modified mallampati score
Periodo de tiempo: Ventilation difficulty scale was assessed after during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed after during mask ventilation
|
|
Correlation of difficult laryngoscopy with neck movement
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
with neck movement
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with dentition
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with dentition
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with upper lip bite test
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with upper lip bite test
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with mouth opening
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with mouth opening
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with sternomental distance
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with sternomental distance
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with breast circumference
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with breast circumference
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with thorax circumference
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with thorax circumference
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with waist circumference
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with waist circumference
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
|
Correlation of difficult laryngoscopy with hip circumference
Periodo de tiempo: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with hip circumference
Periodo de tiempo: Ventilation difficulty scale was assessed during mask ventilation
|
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate.
V3 and V4 was defined as difficult mask ventilation.
|
Ventilation difficulty scale was assessed during mask ventilation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Güniz Köksal, Professor, Istanbul University Cerrahpasa Medical Faculty
Publicaciones y enlaces útiles
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2015
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
26 de octubre de 2015
Publicado por primera vez (Estimar)
28 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de febrero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
10 de febrero de 2016
Última verificación
1 de febrero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 02-887/2
Plan de datos de participantes individuales (IPD)
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INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .