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Comparative Study Between Combined Video Laryngoscope and Video Stylet Intubation Versus Combined Video Laryngoscope and Fiberoptic Intubation in a Simulated Difficult Airway

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Interventions: Fiberoptic bronchoscope (Device), Video stylet (Device) to Video Laryngoscope plus Fiberoptic bronchoscope (Device), Video Laryngoscope plus Video Stylet (Device), Video laryngoscope alone as a…
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description shortened, about 17 words
    • Publications: details revised at 1 of 1 entry
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study titled "Comparative Study Between Combined Video Laryngoscope and Video Stylet Intubation Versus Combined Video Laryngoscope and Fibreoptic Intubation in a Simulated Difficult Airway" aims to evaluate and compare two advanced intubation techniques used in managing difficult airways. Currently, there is no study in Malaysia that compares the combination of a video laryngoscope (VL) with a video stylet (VS) and the combination of VL with a fibreoptic bronchoscope (FOB). Although both methods have been investigated separately, direct comparisons in simulated difficult airway settings are limited. The findings of this study will help guide airway management protocols and improve clinical outcomes in challenging airway situations. This is a single-centre, randomized comparative crossover trial conducted at the Department of Anaesthesiology and Intensive Care, HCTM, UKM. Ethical approval will be obtained from the departmental and university ethics committees prior to commencement. The study population will consist of anaesthesiology medical officers with at least two years of experience and anaesthesiology trainees in their second to fourth year of training at HCTM, UKM. Participants with severe hand tremors or those who decline participation will be excluded. The main objectives are to compare the first-pass intubation success rate, time to successful intubation, and operator-rated ease of intubation between the two combined techniques. Each participant will perform both VL with VS and VL with FOB intubations in a simulated difficult airway scenario. The study hypothesizes that the combined VL with VS technique will provide superior performance, a higher first-pass success rate, shorter intubation time, and greater ease of use compared to the VL with FOB technique. Participants who fail to complete all procedures or withdraw after participation will be considered dropouts. The results from this study are expected to provide useful insights into the effectiveness and practicality of these two combination techniques for airway management training and clinical application.
Trial Details
NCT Number NCT07470736
Lead Sponsor National University of Malaysia
Conditions
(from sponsor)
Video Laryngoscope, Airway, Difficult Airway, Fiberoptic Guided Intubation
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov