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RecruitingNCT07470736Updated Mar 17, 2026

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

An interventional study of Video laryngoscope alone as a control and Video Laryngoscope plus Video Stylet in Video Laryngoscope, Airway and Difficult Airway, sponsored by National University of Malaysia. Recruiting at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by National University of Malaysia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Sex
All
01

Study summary

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.

Read the detailed description

Before the study been conducted, the investigator, will give a 10 minutes briefing and explanation regarding the study and consent will be taken from the participants. Based on the previous study, a video demonstration on using these devices will be shown to participants as well. Participants will be informed at least a day prior to the study conducted so that the investigator and participants can have time to prepare and allocate time for participating in the study respectively.

This study will evaluate three techniques of ETI by participants in a simulated difficult airway scenario. Participants will start off with the single technique using a VL only, which serves as the control and standard care. After completing the single technique, participants will then proceed with both combination techniques, which are combined VL with VS and combined VL with FOB. As this is randomized comparative cross-over simulation study, participants will pick an envelope that randomly stated the sequence of combination techniques which generated using computer randomisation. Each participant on each session may get the same sequence or may not. However, the sequence for the study will be in equal proportion. There will be a washout period of five minutes between each technique. This allows the investigator and participants to chart the results and get ready for the other technique respectively.

The investigator will prepare the video laryngoscope C-MAC® with blade size 3, preformed rigid stylet, monitor, C-MAC® Video Stylet and Karl Storz Fibreoptic Scope which are standardised for all participants. Besides, standard endotracheal tube (ETT) size 8mm internal diameter will be used and lubricated with KY jelly.

Participants will attempt intubation using half body Laerdal Airway Management Trainer manikin. The neck immobilisation will be made by placing a hard cervical collar on the manikin to mimic difficult airway. Before attempting intubation, participants are allowed to practice intubation using VL, combination of VL with VS and combination of VL with FOB for familiarisation with the devices after briefing and video demonstration. Participants need to practice on the normal airway manikin and need to have successful intubation for at least five attempts for each technique which are VL, combined VL with VS and combined VL with FOB before commencing the study on a simulated difficult airway.

As for the study control, participants will start by intubating the manikin using VL C-MAC® with blade size 3. The intubation time for VL will start from VL C-MAC® blade size 3 passes upper incisor till successful ETI using ETT loaded preformed rigid stylet. For the combination techniques, the participant will manoeuvre the VL to optimal position and then held by an assistant. With the VL in situ by the assistant, each participant will advance the VS or FOB through the vocal cord and then the ETT will be advanced under indirect visualisation. The investigator will time the intubation attempts using a standard stopwatch. This study will divide the intubation time for the combined technique into three parts. For the first part, the time will start from the VL blade passes the upper incisors till glottic view (V-G) is obtained. The second intubation time will start when the ETT loaded FOB or VS passes the upper incisors and stops once the ETT loaded FOB or VS passes through the glottic opening (I-G time). For the third part, the timing will start when the ETT loaded FOB or VS passes through the glottic opening and stop upon successful ETI (G-E time). Successful ETI 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. This 60-second time limit is established based on findings from previous difficult airway study. Participants are allowed up to three attempts for each technique. Participants will be considered as drop outs if they do not perform VL and two combination techniques of VL with VS and VL with FOB in one setting, and wish to withdraw from the study even after completing the procedure.

Failure of intubation is defined when the intubation done lasted longer than 60 seconds or if the ETT is placed in the oesophagus. Total time (TT) of intubation for combined techniques will be the sum of V-G, I-G and G-E time. Other variables that will be recorded in this study include glottic visualization which is described according to the Cormack-Lehane (CL) classification and the Percentage of Glottis Opening (POGO) scale even though the CL and POGO scales are used in direct laryngoscopy and VL respectively.

At the end of each technique, participants will be asked to rate the ease of intubation by a 5-point Likert scale from very difficult to very easy and their preference on the combination devices of VL with VS and VL with FOB also will be recorded. All these data will be collected using data collection sheet.

02

Conditions studied

  • Video Laryngoscope
  • Airway
  • Difficult Airway
  • Fiberoptic Guided Intubation

Keywords

  • Video laryngoscope
  • Video sylet intubation
  • Simulated difficult airway
  • Airway
03

In context

Lead sponsor

National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Thsoe who has severe hand tremors.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    This is the control

    Device: Video laryngoscope alone as a control · Device: Video Laryngoscope plus Video Stylet · Device: Video Laryngoscope plus Fiberoptic bronchoscope

  • Experimental
    This is the first intervention group

    Device: Video laryngoscope alone as a control · Device: Video Laryngoscope plus Video Stylet · Device: Video Laryngoscope plus Fiberoptic bronchoscope

  • Experimental
    This is the 2ndd intervention group

    This will be the second interventional group

    Device: Video laryngoscope alone as a control · Device: Video Laryngoscope plus Video Stylet · Device: Video Laryngoscope plus Fiberoptic bronchoscope

Interventions

  • DeviceVideo laryngoscope alone as a control

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

  • DeviceVideo Laryngoscope plus Video Stylet

    This will be the first inteventional group

  • DeviceVideo Laryngoscope plus Fiberoptic bronchoscope

    This will be the second interventional group

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Universiti Kebangsaan Malaysia
    Kuala Lumpur, Bandar Tun Razak 56000, Malaysia
    Recruiting
08

References and documents

Publications

  • La Via, L.; Merola, F.; Messina, S.; Sanfilippo, G.; Tornitore, F.; Lombardo, F.; Sanfilippo, M.; Tigano, S.; Sanfilippo, F. Use of Combined Laryngo-Bronchoscopy Intubation Approach in a Simulated Difficult Airway Scenario with Cervical Stabilization. Signa Vitae 2023, 19, 104-111, doi:10.22514/sv.2023.073. 2. Gunasekaran, K.; Joshi, R.; Karunagaran, P.; Yachendra, V.S.G. A Hybrid Technique Using Video Laryngoscope-Assisted Flexible Bronchoscopy to Facilitate Endotracheal Intubation in Children with Anticipated Difficult Airway: A Case Series. Turk J Anaesthesiol Reanim 2025, 53, 77-81, doi:10.4274/TJAR.2024.241587. 3. Pius, J.; Noppens, R.R. Learning Curve and Performance in Simulated Difficult Airway for the Novel C-MAC® Video-Stylet and C-MAC® Macintosh Video Laryngoscope: A Prospective Randomized Manikin Trial. PLoS One 2020, 15, doi:10.1371/journal.pone.0242154. 4. Pan, H.-S.; Corey, T.; Luk, H.-N.; Qu, J.Z.; Shikani, A. Combined Styletubation with Videolaryngoscopy for Tracheal Intubation in Patients Undergoing Thyroidectomy with Intraoperative Neuromonitoring. Anesthesia Research 2023, 1, 8-23, doi:10.3390/anesthres1010003. 5. Lenhardt, R.; Burkhart, M.T.; Brock, G.N.; Kanchi-Kandadai, S.; Sharma, R.; Akça, O. Is Video Laryngoscope-Assisted Flexible Tracheoscope Intubation Feasible for Patients with Predicted Difficult Airway? A Prospective, Randomized Clinical Trial. Anesth Analg 2014, 118, 1259-1265, doi:10.1213/ANE.0000000000000220. 6. Luk, H.-N.; Luk, H.-N.; Zhensheng Qu, J.; Shikani, A. A Paradigm Shift of Airway Management: The Role of Video-Assisted Intubating Stylet Technique. In Advances in Tracheal Intubation; IntechOpen, 2023. 7. Crawley, S.M.; Dalton, A.J. Predicting the Difficult Airway. BJA Educ 2015, 15, 253-258, doi:10.1093/bjaceaccp/mku047. 8. Kim, S.M.; Kim, H.J. Successful Advancement of Endotracheal Tube with Combined Fiberoptic Bronchoscopy and Videolaryngoscopy in a Patient with a Huge Goiter. SAGE Open Med Case Rep 2020, 8, doi:1

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07470736
Lead sponsor
National University of Malaysia
Responsible party
Mohammad Nizam Mokhtar (Doctor, National University of Malaysia) — Principal investigator
First posted
Mar 13, 2026
Start date
Feb 26, 2026
Primary completion
Sep 14, 2027 (estimated)
Completion
Mar 14, 2028 (estimated)
Last update
Mar 17, 2026

Study contacts

Mohammad Nizam Mokhtar, MBChB
Contact
drnizam@ukm.edu.my
+6091455555 ext. 5785

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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