Comparative Study Between Combined Video Laryngoscope and Video Stylet Intubation Versus Combined Video Laryngoscope and Fiberoptic Intubation in a Simulated Difficult Airway
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2026
CompletedFirst Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 14, 2028
March 17, 2026
March 1, 2026
1.5 years
March 10, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
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.
From enrollment until completion of simulation on the same day
Secondary Outcomes (2)
Compare intubation time between combined videolaryngoscope with video stylet and combined video laryngoscope with fiberoptic bronchoscope.
From enrollment until simulation end at the same day
To evaluate ease of intubation as rated by operators between combined video laryngopscope with video stylet and combined video laryngoscope with fiberoptic bronchoscope.
From enrollment of the study until completion of the simulation on the same day
Study Arms (3)
This is the control
ACTIVE COMPARATORThis is the first intervention group
EXPERIMENTALThis is the 2ndd intervention group
EXPERIMENTALThis will be the second interventional group
Interventions
this is the control arm of the study where it is the standard of care now
This will be the first inteventional group
This will be the second interventional group
Eligibility Criteria
You may qualify if:
- the anaesthesiology medical officers who have at least more than two years of experience.
You may not qualify if:
- Thsoe who has severe hand tremors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universiti Kebangsaan Malaysia
Kuala Lumpur, Bandar Tun Razak, 56000, Malaysia
Related Publications (1)
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
BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 13, 2026
Study Start
February 26, 2026
Primary Completion (Estimated)
September 14, 2027
Study Completion (Estimated)
March 14, 2028
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Mac 2026- Mac 2029
- Access Criteria
- They will be able to gain the access via email the principle investigaror or accessing the repository.
All IPD that underlie results in a publication