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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Kuala Lumpur
-
Petaling Jaya, Kuala Lumpur, Malesia, 59100
- Universiti Malaya Medical Centre
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Channelled blade videolaryngoscope
Endotracheal intubation done with channelled blade videolaryngoscope
|
Intubation with channelled blade videolaryngoscope
|
|
Active Comparator: Non channelled hyperangulated blade videolaryngoscope
Endotracheal intubation done with non channelled hyperangulated blade videolaryngoscope
|
Intubation done by using Non channelled hyperangulated blade videolaryngoscope
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Total Time to intubation
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
First attempt success rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Wei Yen Yeoh, Universiti Malaya
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- RSCH ID-25-06670-TVG
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
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