- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01783366
Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Yangsan, Corea, república de
- Reclutamiento
- Pnuyh Anesthesia
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Sub-Investigador:
- JI WOOK YOON, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled
Exclusion Criteria:
- Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: CONTROL
In the control group (Group A) inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position.
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Comparador activo: tube-exchanger
The tube-exchanger group (Group B) made use of tube-exchanger G36402 (CAEC, [cook medical, Bloomington, IN]) as a stylet that was lubricated and inserted within 20-F NGT until the tip of the tube-exchanger was at the tip of the NGT
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of attempt of NGT insertion
Periodo de tiempo: after successful insertion of NGT, within 1 hr
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After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion through the nostrils until 70cm of NGT was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. Total number of attempts until successful NGT insertion was recorded and tried at least three times, and was considered to have failed. Thus, procedure time would be the dependent factor of primary endpoin which could increse the success rate of NGT. |
after successful insertion of NGT, within 1 hr
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Procedure time of NGT insertion
Periodo de tiempo: after successful insertion of NGT, within 1 hr
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After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position.
The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT.
Success of appropriate NGT insertion was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT.
NGT insertion time recorded when the NGT begun to insert gently through the nostrils until 70cm of NGT.
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after successful insertion of NGT, within 1 hr
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view
Periodo de tiempo: after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
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The investigators examined the occurrence of complication associated with NGT insertion.
After successful NGT insertion, we recorded presence of bleeding of the larynx, and knotting or kinking of NGT using laryngoscopy.
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after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Otros números de identificación del estudio
- PNU03-2013-002
- PNUYH03-2013-002 (Otro identificador: PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL)
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