Channelled Blade Versus Non-Channelled Videolaryngoscope
Comparative Study of the Channelled Blade Astra-Vue Videolaryngoscope and the Non-Channelled CMAC D-Blade Videolaryngoscope in Airway Management: A Randomized Controlled Trial
The goal of this clinical trial is to learn if performance of a channelled blade Astra-Vue videolaryngoscope compared to non channelled hyperangulated C-MAC D-blade videolaryngoscope(Karl Storz, Tuttlingen, Germany) in airway management among adults undergoing elective surgery under general anesthesia. The main primary outcomes measured is the overall time taken to intubation, secondary measures includes the first attempt success rate, ease with intubation and associated complication
Participants are of adults who planned for elective or semi emergency surgery under general anesthesia. They will be screened and recruited with informed and written consent. Intubation information will be collected
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This randomized controlled trial aims to compare the performance of a channelled videolaryngoscope (AstraVue videolaryngoscope) with a non-channelled hyperangulated videolaryngoscope (C-MAC™ D-Blade videolaryngoscope, Karl Storz, Tuttlingen, Germany) in adult patients undergoing elective or semi-emergency surgery under general anaesthesia requiring endotracheal intubation.
Participants will be randomly assigned to intubation using either the channelled AstraVue videolaryngoscope or the non-channelled C-MAC D-Blade videolaryngoscope. Standard anaesthesia induction protocols will be followed.
The primary outcome is the total time to successful intubation. Secondary outcomes include time to glottic visualization, time from glottic visualization to intubation, first-attempt success rate, number of attempts, need for external laryngeal manipulation, haemodynamic responses, and intubation-related complications.
Data will be collected prospectively during the peri-intubation period. The study aims to evaluate whether the channelled design improves intubation efficiency and success compared to the non-channelled videolaryngoscope.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kuala Lumpur
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Petaling Jaya, Kuala Lumpur, Malaisie, 59100
- Universiti Malaya Medical Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adult patients aged 18 to 70 years old requiring endotracheal intubation for elective or semi-emergency surgery under general anaesthesia
- ASA I, II and stable ASA III patients
- Patient with Mallampati Score Grade 1 to 3
Exclusion Criteria:
- Patients with known airway abnormalities or anticipated difficult intubation,
- Patients with desaturation before intubation,
- Patients with high risk for aspiration requiring rapid sequence induction
- Patient with known cervical pathology.
- Patient refuse to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Channelled blade videolaryngoscope
Endotracheal intubation done with channelled blade videolaryngoscope
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Intubation with channelled blade videolaryngoscope
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Comparateur actif: Non channelled hyperangulated blade videolaryngoscope
Endotracheal intubation done with non channelled hyperangulated blade videolaryngoscope
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Intubation done by using Non channelled hyperangulated blade videolaryngoscope
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Time to intubation
Délai: During the intubation procedure (within minutes after induction of general anaesthesia)
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time from insertion of laryngoscope blade through incisor teeth to visualization of Endotracheal tube into trachea, measured in seconds
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During the intubation procedure (within minutes after induction of general anaesthesia)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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First attempt success rate
Délai: During the intubation procedure(within minutes after induction of general anaesthesia)
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Successful endotracheal intubation on the first attempt, measured as a proportion of total intubations(%)
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During the intubation procedure(within minutes after induction of general anaesthesia)
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Time to Glottic Visualization
Délai: During the intubation procedure(within minutes after induction of general anaesthesia)
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time from insertion of laryngoscope blade to visualization of glottis, measured in seconds
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During the intubation procedure(within minutes after induction of general anaesthesia)
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Ease of intubation
Délai: During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia)
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Ease of intubation assessed using a modified Intubation Difficulty Scale (IDS), which includes parameters such as number of attempts, additional operators, alternative techniques, lifting force, external laryngeal pressure, vocal cord position, and intubation difficulty.
The total score ranges from 0 to ≥5, where a score of 0 classified as easy, 1 to 5 classified as slight difficulty, and >5 as moderate to major difficulty, generally higher score means increasing difficulty
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During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia)
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Change in Mean Arterial Pressure from baseline
Délai: Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation
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Change in Mean arterial pressure measured at 1 minute after successful intubation, expressed as percentage change from baseline value
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Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation
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Change in Heart rate from baseline
Délai: Baseline measured prior to intubation, second reading repeat at 1 minute post intubation
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Change in heart rate measured at 1 minute after succesful intubation, expressed as percentage change from baseline value
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Baseline measured prior to intubation, second reading repeat at 1 minute post intubation
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wei Yen Yeoh, Universiti Malaya
Publications et liens utiles
Publications générales
- Shin KW, Lee SP, Kim T, Choi S, Kim YJ, Park HP, Oh H. Channelled versus nonchannelled Macintosh videolaryngoscope blades in patients with a cervical collar: a randomized controlled noninferiority trial. Can J Anaesth. 2024 Sep;71(9):1261-1271. doi: 10.1007/s12630-024-02769-3. Epub 2024 May 22.
- Chandy J, Pillai R, Mathew A, Philip AV, George SP, Sahajanandan R. A randomized clinical trial comparing the King Vision (channeled blade) and the CMAC (D blade) videolaryngoscopes in patients with cervical spine immobilization. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):604-609. doi: 10.4103/joacp.JOACP_75_20. Epub 2022 Jan 6.
- Biro P, Schlaepfer M. Tracheal intubation with channeled vs. non-channeled videolaryngoscope blades. Rom J Anaesth Intensive Care. 2018 Oct;25(2):97-101. doi: 10.21454/rjaic.7518.252.sch.
- Hirabayashi Y, Hoshijima H, Kuratani N. [Channeled videolaryngoscope: A meta-analysis of randomized controlled trials]. Masui. 2013 Jul;62(7):886-93. Japanese.
- Decamps P, Grillot N, Le Thuaut A, Brule N, Lejus-Bourdeau C, Reignier J, Lascarrou JB. Comparison of four channelled videolaryngoscopes to Macintosh laryngoscope for simulated intubation of critically ill patients: the randomized MACMAN2 trial. Ann Intensive Care. 2021 Aug 16;11(1):126. doi: 10.1186/s13613-021-00916-3.
- Mendonca C, Ungureanu N, Nowicka A, Kumar P. A randomised clinical trial comparing the 'sniffing' and neutral position using channelled (KingVision(R) ) and non-channelled (C-MAC(R) ) videolaryngoscopes. Anaesthesia. 2018 Jul;73(7):847-855. doi: 10.1111/anae.14289. Epub 2018 Apr 16.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
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
Mots clés
Autres numéros d'identification d'étude
- RSCH ID-25-06670-TVG
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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