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Video Analysis of Prehospital Emergency Intubations

6 mai 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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

Type d'étude

Observationnel

Inscription (Réel)

422

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Suisse
- - Bern, Suisse, 3011
    - Bern University Hospital and University of Bern

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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).

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
First attempt intubation success rate Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Overall success rate Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital Inselspital, Berne

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 février 2018

Achèvement primaire (Réel)

14 février 2019

Achèvement de l'étude (Réel)

14 février 2019

Dates d'inscription aux études

Première soumission

17 avril 2019

Première soumission répondant aux critères de contrôle qualité

24 avril 2019

Première publication (Réel)

29 avril 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2019

Dernière vérification

1 mai 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

2017-02104

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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