Comparison of Miller's Blade and Airtraq Laryngoscope in Children
11 de febrero de 2016 actualizado por: Bikramjit Das, Government Medical College, Haldwani
A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
The Airtraq optical laryngoscope has recently been available in pediatric sizes.
The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients.
This prospective, randomized study was conducted in a tertiary care teaching hospital.
Sixty American Society of Anesthesiologists (ASA) grade I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30) laryngoscope.
The primary outcome measures were time of intubation, ease of intubation, number of attempts and POGO score.
We also measured hemodynamic changes and airway trauma.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.
The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.
Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
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
2 años a 10 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- American Society of Anesthesiologists physical status I-II,
- elective surgeries requiring tracheal intubation
Exclusion Criteria:
- patients with upper respiratory tract symptoms,
- those at risk of gastroesophageal regurgitation and
- those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intubation with Miller's blade
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth.
After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
|
Intubation is insertion of a hollow tube inside the trachea.
It is done after laryngoscopy with Miller's blade.
|
|
Experimental: Intubation with Airtraq laryngoscope
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth.
After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
|
Intubation is insertion of a hollow tube inside the trachea.
It is done after laryngoscopy with Airtraq.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Intubation
Periodo de tiempo: 5 minutes
|
It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform
|
5 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Intubation in First Attempts;
Periodo de tiempo: 5 minutes
|
A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.
|
5 minutes
|
|
Ease of Intubation.
Periodo de tiempo: 5 minutes
|
The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.
|
5 minutes
|
|
Percentage of Glottic Opening Scoring.
Periodo de tiempo: 5 minutes
|
The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch
|
5 minutes
|
|
Overall Intubation Success Rate.
Periodo de tiempo: 5 minutes
|
It is the number of participants who were successfully intubated after first, second or third attempts.
Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.
|
5 minutes
|
|
Number of Esophageal Intubation.
Periodo de tiempo: 5 minutes
|
Insertion of tracheal tube inside the esophagus
|
5 minutes
|
|
Number of Participants With Airway Trauma
Periodo de tiempo: 5 minutes
|
Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.
|
5 minutes
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Shahin N Jamil, M.D., J.N.Medical College, Aligarh Muslim University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
- Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
- White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AY, Medlock KE, Mason DG. A randomised, controlled trial comparing the Airtraq optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia. 2012 Mar;67(3):226-31. doi: 10.1111/j.1365-2044.2011.06978.x.
Enlaces Útiles
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 mayo de 2013
Finalización primaria (Actual)
1 de mayo de 2014
Finalización del estudio (Actual)
1 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
29 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de abril de 2015
Publicado por primera vez (Estimar)
22 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
11 de febrero de 2016
Última verificación
1 de febrero de 2016
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- DN 182/FM
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