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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational University of Malaysia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

the anaesthesiology medical officers who have at least more than two years of experience.

Disqualifiers

Thsoe who has severe hand tremors.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Video laryngoscope alone as a control

    Device

    this is the control arm of the study where it is the standard of care now

  • Video Laryngoscope plus Video Stylet

    Device

    This will be the first inteventional group

  • Video Laryngoscope plus Fiberoptic bronchoscope

    Device

    This will be the second interventional group

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: This is the controlActive comparator 3 interventions
Group B: This is the first intervention groupExperimental treatment 3 interventions
Group C: This is the 2ndd intervention groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

compare first-pass intubation success rate between combined video laryngoscope with video stylet and combined video laryngoscope with fiberoptic bronchoscope.

Successful endotracheal intubation is defined once the real time video monitoring shows the ETT passes through the vocal cord and chest inflation is observed upon bag insufflation within 60 seconds of intubation by the participant.

Time frame
From enrollment until completion of simulation on the same day

Secondary outcomes

1

Compare intubation time between combined videolaryngoscope with video stylet and combined video laryngoscope with fiberoptic bronchoscope.

It is the time taken during successful endotracheal intubation

Time frame
From enrollment until simulation end at the same day
2

To evaluate ease of intubation as rated by operators between combined video laryngopscope with video stylet and combined video laryngoscope with fiberoptic bronchoscope.

At the end of each technique, participants will be asked to rate the ease of intubation from very difficult mark 5 to very easy mark as 1 and need to state their preference on the combination devices.

Time frame
From enrollment of the study until completion of the simulation on the same day

Other outcomes

Sponsors and contacts

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