Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Forces applied on soft upper tissues by different laryngoscope blades during direct laryngoscopy and intubation are considered to be major stimuli to cause serious damages to the patients, such as local injures to incisors, larynx and spinal column, or hemodynamic changes in heart rate and/or blood pressure due to autonomic nervous system stimulation.
In order to reduce risk of such injures, indirect videolaryngoscopy provides the advantage of an easier laryngeal visualization with less need for the mouth-pharyngeal-laryngeal axes alignment, thereby reducing the detrimental effects above mentioned.
The aim of this study is to measure the minimal force exertion to achieve not only glottis view but also a successful intubation, comparing GlideScope and Macintosh laryngoscope, in patients with normal airway conditions. Furthermore, The investigators measured the following parameters: pressure distribution upon the blade; time required to visualize the glottis; time required to complete oro-tracheal intubation.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Rome, Italie, 00128
- University Hospital Campus BioMedico
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients classified as American Society of Anesthesiologists physical status (ASA-PS) class 1 or 2
- Patients whose intubation was associated with a Cormack-Lehane grade 1
Exclusion Criteria:
- younger than 18 yrs
- older than 65 yrs
- body-mass index (BMI) between 18 and 30
- predicted difficult intubation according to SIAARTI (Italian Society Anaesthesia, Analgesia, Resuscitation and Intensive Care)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Direct laryngoscope
Includes cases in which the forces applied by Macintosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.
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Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
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Comparateur actif: Indirect laryngoscope
Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.
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Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.
Délai: Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
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The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.
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Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation
Délai: On average 20 seconds
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Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.
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On average 20 seconds
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Massimiliano Carassiti, Professor, Campus Biomedico
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Mots clés
Autres numéros d'identification d'étude
- PressureCara
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