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CTRI Number  CTRI/2024/05/067243 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare passing of a plastic tube into patients windpipe with and without the use of a metal rod(stylet) during operation under general anaesthesia. 
Scientific Title of Study   comparison of intubation using VL3 video laryngoscope with and without stylet: A prospective randomized study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ch Sai Mounika 
Designation  Junior Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology Second floor OT complex M S Ramaiah Medical College Hospital MSRIT Post New BEL road Bangalore
Department of Anaesthesiology Second floor OT complex M S Ramaiah Medical College Hospital MSRIT Post New BEL road
Bangalore
KARNATAKA
560054
India 
Phone  9346961976  
Fax    
Email  mounikachallagulla96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  MS Ramaiah Medical College Hospital 
Address  Department of Anaesthesiology Second floor OT complex MS Ramaiah Medical College Hospital MSRIT Post New BEL Road Bangalore
Department of Anaesthesiology Second floor OT complex MS Ramaiah Medical College Hospital MSRIT Post New BEL Road
Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  MS Ramaiah Medical College Hospital 
Address  Department of Anaesthesiology Second floor OT complex MS Ramaiah Medical College Hospital MSRIT Post New BEL Road Bangalore
Department of Anaesthesiology Second floor OT complex MS Ramaiah Medical College Hospital MSRIT Post New BEL Road
Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College Hospital 
 
Primary Sponsor  
Name  MS Ramaiah Medical College Hospital 
Address  MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore 560054 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejesh C A  MS Ramaiah Medical College Hospital   Department of Anaesthesiology Second floor OT complex MS Ramaiah Medical College Hospital MSRIT Post New BEL Road Bangalore 560064 India
Bangalore
KARNATAKA 		 9886481848

drtejeshca@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah medical college Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy humans scheduled to undergo surgery requiring general anesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intubation will be facilitated without the use of stylet  The endotracheal tube will be bent to exaggerate its curvature by joining the distal tip of the tube for 3minutes prior to intubation 
Intervention  Use of a stylet to facilitate endotracheal intubation  The endotracheal tube will be reinforced with a metal stylet for facilitating intubation 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American society of Anaesthesiologists ASA physical status 1 and 2 patients scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  Anticipated difficult airway
Previous history of dental pathology
Previous surgery to mouth pharynx larynx or cervical spine
Increased risk of aspiration
Pregnancy
BMI more than 35
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the Time to successful intubation with VL3 video laryngoscope   1 minute after intubation  
 
Secondary Outcome  
Outcome  TimePoints 
POGO score
 		 1 minute after intubation
 
Intubation Difficulty Score  2 minutes after intubation 
Ease of Intubation  2 minutes after intubation 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  On contacting the primary investigator by mail

  6. For how long will this data be available start date provided 30-11-2026 and end date provided 30-11-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Video laryngoscopes are an important advancement in the practice of clinical anaesthesia. Their role is now well established in difficult or failed direct laryngoscopy and also as an educational tool. These are the devices with a video camera positioned near the tip of the laryngoscope blade, thus allowing to ’see the corners’ of the upper airway obviating the need to align the airway axes to obtain a laryngeal view which invariably provide a better glottic view than direct laryngoscope, however this does not assure an easy intubation. There can be difficulty encountered to direct the endotracheal tube towards the glottic opening leading to an increased time to intubation. To overcome this, the use of stylet is found to be very effective in facilitating orotracheal intubation using video laryngoscope.

The GlideRite rigid stylet is a commercially available stylet with a preformed curvature and is designed to facilitate intubation with a GlideScope video laryngoscope. However, it can be used for other video laryngoscopes. The VL3 video laryngoscope (HugeMed, Shenzhen) is a new portable device for performing endotracheal intubation. It weighs 350g and has a 3.5inch display with a 2.0 Megapixel camera near the tip of the blade. It is available in neonatal, pediatric, and adult sizes in both reusable and disposable versions.

There is paucity of literature evaluating VL3 video laryngoscope and hence the present study was designed to evaluate its role in facilitating orotracheal intubation with and without the use of GlideRite rigid stylet. We hypothesized that the use of stylet will lead to a faster intubation with VL3 video laryngoscope than without stylet.
 
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