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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Kuala Lumpur
-
Petaling Jaya, Kuala Lumpur, Malaysia, 59100
- Universiti Malaya Medical Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Channelled blade videolaryngoscope
Endotracheal intubation done with channelled blade videolaryngoscope
|
Intubation with channelled blade videolaryngoscope
|
|
Aktiv komparator: Non channelled hyperangulated blade videolaryngoscope
Endotracheal intubation done with non channelled hyperangulated blade videolaryngoscope
|
Intubation done by using Non channelled hyperangulated blade videolaryngoscope
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total Time to intubation
Tidsram: During the intubation procedure (within minutes after induction of general anaesthesia)
|
time from insertion of laryngoscope blade through incisor teeth to visualization of Endotracheal tube into trachea, measured in seconds
|
During the intubation procedure (within minutes after induction of general anaesthesia)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
First attempt success rate
Tidsram: During the intubation procedure(within minutes after induction of general anaesthesia)
|
Successful endotracheal intubation on the first attempt, measured as a proportion of total intubations(%)
|
During the intubation procedure(within minutes after induction of general anaesthesia)
|
|
Time to Glottic Visualization
Tidsram: During the intubation procedure(within minutes after induction of general anaesthesia)
|
time from insertion of laryngoscope blade to visualization of glottis, measured in seconds
|
During the intubation procedure(within minutes after induction of general anaesthesia)
|
|
Ease of intubation
Tidsram: During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia)
|
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
|
During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia)
|
|
Change in Mean Arterial Pressure from baseline
Tidsram: Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation
|
Change in Mean arterial pressure measured at 1 minute after successful intubation, expressed as percentage change from baseline value
|
Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation
|
|
Change in Heart rate from baseline
Tidsram: Baseline measured prior to intubation, second reading repeat at 1 minute post intubation
|
Change in heart rate measured at 1 minute after succesful intubation, expressed as percentage change from baseline value
|
Baseline measured prior to intubation, second reading repeat at 1 minute post intubation
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Wei Yen Yeoh, Universiti Malaya
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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Nyckelord
Andra studie-ID-nummer
- RSCH ID-25-06670-TVG
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