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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kuala Lumpur
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Petaling Jaya, Kuala Lumpur, Maleisië, 59100
- Universiti Malaya Medical Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Channelled blade videolaryngoscope
Endotracheal intubation done with channelled blade videolaryngoscope
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Intubation with channelled blade videolaryngoscope
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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total Time to intubation
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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First attempt success rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Wei Yen Yeoh, Universiti Malaya
Publicaties en nuttige links
Algemene publicaties
- 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.
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- RSCH ID-25-06670-TVG
Plan Individuele Deelnemersgegevens (IPD)
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