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

Comparative Study Between Combined Video Laryngoscope and Video Stylet Intubation Versus Combined Video Laryngoscope and Fiberoptic Intubation

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.

Study Overview

• Status: Recruiting
• Conditions: Difficult Airway; Airway; Fiberoptic Guided Intubation; Video Laryngoscope
• Intervention / Treatment: Device: Video laryngoscope alone as a control; Device: Video Laryngoscope plus Video Stylet; Device: Video Laryngoscope plus Fiberoptic bronchoscope

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Nizam Mokhtar, MBChB; Phone Number: 5785 +6091455555; Email: drnizam@ukm.edu.my

Study Locations

• Malaysia
  • Bandar Tun Razak
    • Kuala Lumpur, Bandar Tun Razak, Malaysia, 56000
      • Recruiting
      • Universiti Kebangsaan Malaysia
      • Contact: Nor Shazrina Md Saad, MD; Phone Number: +60129530246; Email: nshazrina@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Thsoe who has severe hand tremors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: This is the control	Device: Video laryngoscope alone as a control; this is the control arm of the study where it is the standard of care now; Device: Video Laryngoscope plus Video Stylet; This will be the first inteventional group; Device: Video Laryngoscope plus Fiberoptic bronchoscope; This will be the second interventional group
Experimental: This is the first intervention group	Device: Video laryngoscope alone as a control; this is the control arm of the study where it is the standard of care now; Device: Video Laryngoscope plus Video Stylet; This will be the first inteventional group; Device: Video Laryngoscope plus Fiberoptic bronchoscope; This will be the second interventional group
Experimental: This is the 2ndd intervention group; This will be the second interventional group	Device: Video laryngoscope alone as a control; this is the control arm of the study where it is the standard of care now; Device: Video Laryngoscope plus Video Stylet; This will be the first inteventional group; Device: Video Laryngoscope plus Fiberoptic bronchoscope; This will be the second interventional group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	From enrollment of the study until completion of the simulation on the same day

Collaborators and Investigators

• Sponsor: National University of Malaysia

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): September 14, 2027
• Study Completion (Estimated): March 14, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Airway; Video laryngoscope; Simulated difficult airway; Video sylet intubation
• Other Study ID Numbers: JEP-2025-1094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Mac 2026- Mac 2029
• IPD Sharing Access Criteria: They will be able to gain the access via email the principle investigaror or accessing the repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No