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Videolaryngoscopes for Double Lumen Tube Intubations in Simulated Easy and Difficult Airway

24 décembre 2015 mis à jour par: Imam Abdulrahman Bin Faisal University

A Comparison of Three Videolaryngoscopes for Double-lumen Tubes Intubation in Simulated Easy and Difficult Airways

The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures.

Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.

Aperçu de l'étude

Description détaillée

Several regional surveys demonstrated that most thoracic anesthesiologists are using the double-lumen endobronchial tubes (DLT) as the first-choice lung separation technique. DLT, when compared with single lumen tracheal tube, can be more difficult to insert in patients with difficult airways. The videolaryngoscopes (VL) have the potential to facilitate the placement of the DLTs for lung separation in patients with predicted or unanticipated difficult airway.

The use of GlideScope® (Verathon Inc., Bothell, WA, USA), a VL with an angulated blade, has been associated with variable times to DLT intubation according to the prior experience of the operators, despite superior visualization of the glottis The channeled Airtraq® (Prodol Meditec S.A., Vizcaya, Spain) and standard non-channeled blade of the King Vision™ (Ambu, Ballerup, Copenhagen, Denmark), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT. Of note, the longer times to DLT intubation with the use of different VL could be shortened with building up the operator's experience.

To the best of the investigators knowledge, the comparison of the effects of the Macintosh, GlideScope®, Airtraq®, and King Vision™ VL on the time to DLT intubation in simulated easy and difficult airways has not yet been studied.

Two high-fidelity simulators (Airway Management Trainer, model AA-3100, Laerdal, Kent, UK) were prepared to simulate easy and difficult airway situations, as described by Marshall et al. and Wang et al. The "easy" airway was established with the manikin in a neutral position. The "difficult" airway setting was obtained by placing an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA) under the occiput and securing the head position with adhesive tape, object to replicate cervical-collar use. Positioning was confirmed after each attempt to ensure consistency.

Type d'étude

Interventionnel

Inscription (Réel)

21

Phase

  • N'est pas applicable

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

    • EP
      • Al-Khobar, EP, Arabie Saoudite, 31952
        • Dammam University KFHU

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

23 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Staff anesthesiologists
  • Signed consent
  • Limited experience in using videolaryngoscopes for inserting double lumen tubes

Exclusion Criteria:

  • Decline to sign the consent
  • Non receiving the prior training demonstration
  • Non practicing once with each device tested on each simulator scenario

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

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Macintosh
The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator
Comparateur placebo: GlideScope
The participants intubated the easy airway simulator with a double lumen tube using the GlideScope laryngoscope followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator
Comparateur actif: Airtraq
The participants intubated the easy airway simulator with a double lumen tube using the Airtraq laryngoscope followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator
Comparateur actif: King Vision
The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time to achieve successful double lumen tube intubation
Délai: for 6 min after using each device
defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).
for 6 min after using each device

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Best view during laryngoscopy using the classification described by Cormack and Lehane
Délai: for 1 min after laryngoscopy
using the classification described by Cormack and Lehane
for 1 min after laryngoscopy
Difficulty of intubation using a Visual Analog Scale (VAS)
Délai: for 6 min after using each device
The difficulty of intubation was evaluated using a visual analog scale (VAS) (ranging from 0: extremely easy, to 100: extremely difficult) expressed by the anesthesiologists after the DLT intubation
for 6 min after using each device
Number of first-pass success
Délai: for 3 min after using each device
first-pass success calculated as number of first-attempt successes/number of patients with an intubation attempt
for 3 min after using each device
Number of the required optimisation manoeuvers
Délai: for 6 min after using each device
When the anaesthesiologists encountered difficulty in visualising vocal cords or placing the tube, they were allowed to use any manoeuver they would normally use to navigate the tube into the trachea including readjustment of the blade or tube or to ask the supervising investigator to help solve the problem, and gave suggestions or instructions
for 6 min after using each device

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Mohamed R El Tahan, MD, Anesthesiology Department, Dammam University, Dammam, Saudi Arabia
  • Directeur d'études: Abdulmohsen A Al Ghamdi, MD, Anesthesiology Department, Dammam University, Dammam, Saudi Arabia

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

1 mars 2015

Achèvement primaire (Réel)

1 mai 2015

Achèvement de l'étude (Réel)

1 juin 2015

Dates d'inscription aux études

Première soumission

22 décembre 2015

Première soumission répondant aux critères de contrôle qualité

24 décembre 2015

Première publication (Estimation)

28 décembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

28 décembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 décembre 2015

Dernière vérification

1 décembre 2015

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • ANESTH-03-15

Plan pour les données individuelles des participants (IPD)

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NON

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