Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting (AMAC)
In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients.
To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated.
As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself.
Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation.
Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate.
Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy.
Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications.
The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy.
The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.
Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Baudoin Clémence
- Numéro de téléphone: +331 49 95 61 61
- E-mail: clemence.baudoin@aphp.fr
Sauvegarde des contacts de l'étude
- Nom: Matthieu Resche-Rigon
- Numéro de téléphone: +33142499773
- E-mail: matthieu.resche-rigon@u-paris.fr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age more than 18
- Indication of orotracheal intubation
- Operators trained to the use of the McGrath
Exclusion Criteria:
- Pregnancy
- No insurance
- Major patient under guardianship or curatorship
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Videolaryngoscopy group
|
Tracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing).
If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
|
|
Autre: Direct laryngoscopy group
|
Tracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention.
and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing).
If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of successful intubation at the first attempt
Délai: up to 10 minutes post inclusion
|
One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
|
up to 10 minutes post inclusion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of attempts needed for successful intubation
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Time to intubate
Délai: up to 10 minutes post inclusion
|
Time to intubate will be defined by the time between the insertion of the device in the mouth and the visualisation of the first waves of EtCO2
|
up to 10 minutes post inclusion
|
|
Reason of failure of the first-pass success
Délai: up to 10 minutes post inclusion
|
Reasons of failure will be defined as following :
|
up to 10 minutes post inclusion
|
|
Proportion of decision of switch in case of failure
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Proportion of difficult intubations
Délai: up to 10 minutes post inclusion
|
Difficult intubation will be evaluated by the intubation difficulty score (score IDS or difficulty of intubation under laryngoscopy score ).
It goes from 0 to infinity.
zero indicating an easy intubation and infinity being an impossible intubation
|
up to 10 minutes post inclusion
|
|
Glottic view
Délai: up to 10 minutes post inclusion
|
Glottic view will be evaluated with Cormack and Lehane grade and POGO score.
POGO score goes from 0 (Visualization of the language base) to 100% (total visualization of the glottis).
Cormack and Lehane grade goes from I to IV.
A higher Cormack and Lehane grade is worth : I indicate total visualization of the glottis and IV indicate Visualization of the language base
|
up to 10 minutes post inclusion
|
|
Proportion of cases who need for tools to optimize
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Proportion of cases needed crossovers to other rescue techniques
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Number of complications per and post-intubation
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Type of complications per and post-intubation
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Number of deaths
Délai: up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K170405J
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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