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Video Analysis of Prehospital Emergency Intubations

6 de mayo de 2019 actualizado por: University Hospital Inselspital, Berne

Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes

The Investigators' knowledge about pre-hospital emergency intubations is still limited. Various factors such as the average and the normal range of intubation time are still unknown. Since its launch Rega videotapes all intubation attempts with the C-MAC videolaryngoscope. The investigators prospectively analysed all routinely recorded intubation videos during one year performed by the Rega crews. The investigators analysed different parameters such as first pass success rate and the time to successfully intubate alongside with others. The goal was to find out more about this difficult procedure, about the problems which regularly occur and on what should be put particular emphasis during training.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Pre-hospital emergency intubations are especially hazardous. The incidence of unanticipated difficult airways is higher (9,3 % of prehospital intubations are more difficult than anticipated). The first attempt intubation success rates are lower and the rate of complications compared to in-hospital emergency intubations is higher.

There is conflicting evidence if first attempt intubation success rate in prehospital intubations differs between intubations performed by videolaryngoscopy and direct laryngoscopy. On the other hand in pre-hospital airway management, the use of a C-MAC videolaryngoscope improved the visualization of glottic structures significantly.

The C-MAC has recently launched a new version, which allows videotaping of intubations. Rega decided to videotape all intubation attempts for legal purposes and quality control. These videos are stored at a Rega-based secure central database.

The Investigators knowledge there is only one video-enhanced retrospective analyses of a limited number of videolaryngoscopic pre-hospital intubations.

So far, there is no video-enhanced prospective analysis of first attempt intubation success rates or of the time necessary for successful intubation with videolaryngoscopes in the pre-hospital setting available. Therefore, the investigators intend to determine the exact first attempt intubation success rate and the time necessary to successfully intubate, alongside with parameters such as the Cormack/Lehane grade, blade position (Macintosh vs Miller) and others (e.g. difficulties during intubation) in the pre-hospital physician-staffed HEMS-setting. The investigators' goal is to learn more about what is actually happening during prehospital intubations and what type of difficulties may occur.

The investigators therefore prospectively analysed all routinely recorded intubation videos (using the built-in camera of the C-MAC videolaryngoscope) during one year performed by the Rega crews. These videos show real life intubations through the video function included in the device, only the image from the tip of the laryngoscopy blade inside the patient's mouth is recorded. The operating physicians additionally provided anonymous information about intubation management for each video after returning to the helicopter base

Tipo de estudio

De observación

Inscripción (Actual)

422

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

  • Suiza
      • Bern, Suiza, 3011
        • Bern University Hospital and University of Bern

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

All Patients which underwent Intubation performed by the Rega during 1year (15.02.18-14.02.19) because of medical or Trauma associated reasons (with or without cardiac arrest).

Descripción

Inclusion Criteria:

• All videos routinely taken from intubations performed during 1 year at the Swiss Air Rescue (Rega) at all 13 helicopter bases

Exclusion Criteria:

  • Patients who were intubated primarily using other devices without a camera
  • Intubations that were not recorded (missing data).

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
First attempt intubation success rate
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Rate of a successful intubation at first attempt
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall success rate
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
The overall rate of successful intubation
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Time intervals during intubation
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
entry-to-tube time (C-MAC crossing the lips to first appearance of tracheal tube in the field of view), time to intubation (C-MAC crossing the lips for the first time until passage of the tube through the vocal cords, the video is kept running throughout the intubation procedure), time between passage of the tube until removal of the blade from the mouth, overall time (from C-MAC crossing the lips for the first time until removal, the video is kept running throughout the intubation procedure), tube time (time from first appearance of the tube in the field until passage of the tube through the vocal cords), intubation time of the successful intubation attempt (C-MAC crossing the lips in the successful attempt until passage of the tube through vocal cords)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of intubation attempts
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
The total number of attempts needed for the intubation
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Best C/L(Cormack/ Lehane 1-4) grade and best POGO (percent of glottis Opening 0 - 100 %) score
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
The best C/L and best POGO score achieved during the intubation
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Additional Airway devices used
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
If additional devices have been used (e.g. Frova-like,catheter, Magill forceps, suction catheter)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of glottic hits
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of attempts to advance the tracheal tube, but only glottic structures are being hit
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Blade positioning
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Blade positioning during intubation (Macintosh vs. Miller)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Unintended blade positions
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Unintended blade positions (too deep, downfolding of epiglottis)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Secretion in the mouth and difficulties in visualisation because of it
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Vomit, blood, saliva
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Fogging of the camera
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
videolaryngoscope camera clear or fog
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Oesophageal intubation
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Oesophageal fail intubation during the procedure
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Injury of the pharyngeal mucose due to the blade
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Videolaryngoscope injury of the pharyngeal mucose due to the blade
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Open or Closed vocal cords
Periodo de tiempo: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Positioning of vocal cords if visible (open, closed), start of movement of vocal cords
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital Inselspital, Berne

Investigadores

  • Investigador principal: Lorenz Theiler, Prof., Department of Anaesthesiology and Pain Therapy, Bern University Hospital

Publicaciones y enlaces útiles

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Publicaciones Generales

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 (Actual)

15 de febrero de 2018

Finalización primaria (Actual)

14 de febrero de 2019

Finalización del estudio (Actual)

14 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

17 de abril de 2019

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2019

Publicado por primera vez (Actual)

29 de abril de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2017-02104

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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