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Channelled Blade Versus Non-Channelled Videolaryngoscope

4. maj 2026 opdateret af: Yeoh Wei Yen, University of Malaya

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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Malaysia
    • Kuala Lumpur
      • Petaling Jaya, Kuala Lumpur, Malaysia, 59100
        • Universiti Malaya Medical Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Channelled blade videolaryngoscope
Endotracheal intubation done with channelled blade videolaryngoscope
Enhed: channelled blade videolaryngoscope
Intubation with channelled blade videolaryngoscope
Aktiv komparator: Non channelled hyperangulated blade videolaryngoscope
Endotracheal intubation done with non channelled hyperangulated blade videolaryngoscope
Enhed: Non channelled hyperangulated blade videolaryngoscope
Intubation done by using Non channelled hyperangulated blade videolaryngoscope

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Time to intubation
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
First attempt success rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Efterforskere

  • Ledende efterforsker: Wei Yen Yeoh, Universiti Malaya

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2025

Primær færdiggørelse (Faktiske)

31. marts 2026

Studieafslutning (Anslået)

31. maj 2026

Datoer for studieregistrering

Først indsendt

15. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RSCH ID-25-06670-TVG

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Luftvejsstyring

Kliniske forsøg med channelled blade videolaryngoscope

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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