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Video Analysis of Prehospital Emergency Intubations

6 de maio de 2019 atualizado 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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

422

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
First attempt intubation success rate
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall success rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de fevereiro de 2018

Conclusão Primária (Real)

14 de fevereiro de 2019

Conclusão do estudo (Real)

14 de fevereiro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

17 de abril de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de abril de 2019

Primeira postagem (Real)

29 de abril de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de maio de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2019

Última verificação

1 de maio de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2017-02104

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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