FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037637 [Registered on: 27/10/2021] Trial Registered Prospectively
Last Modified On: 22/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between HugeMed Videolaryngoscope and Macintosh laryngoscope. 
Scientific Title of Study   ENDOTRACHEAL INTUBATION USING VIDEO LARYNGOSCOPE VERSUS DIRECT LARYNGOSCOPE IN NON EMERGENCY SURGERIES:A RANDOMIZED PARALLEL GROUP STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gourav sharma 
Designation  Post Graduate student 
Affiliation  Government Medical College Jammu 
Address  Department of Anesthesia and Critical Care Medicine Ward 3 GMC Jammu.

Jammu
JAMMU & KASHMIR
180001
India 
Phone  09596648672  
Fax    
Email  sharmagori786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali Mehta 
Designation  Associate Professor 
Affiliation  Department of Anesthesiology and Intensive Care GMC, Jammu. 
Address  Department of Anesthesia and Critical Care Medicine GMC Jammu.

Jammu
JAMMU & KASHMIR
180001
India 
Phone  9419181927  
Fax    
Email  amehta2k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjali Mehta 
Designation  Associate Professor 
Affiliation  Department of Anesthesiology and Intensive Care GMC, Jammu. 
Address  Department of Anesthesia and Critical Care Medicine Ward 3 GMC Jammu.

Jammu
JAMMU & KASHMIR
180001
India 
Phone  9419181927  
Fax    
Email  amehta2k@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College Jammu 
 
Primary Sponsor  
Name  Government Medical College Jammu 
Address  GMC jammu 18001 
Type of Sponsor  Government 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 
Gourav Sharma  Government medical college   Department of Anaesthesiology and Critical Care Medicine Ward 3 GMC jammu 180001
Jammu
JAMMU & KASHMIR 		 9596648672

sharmagori786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Huge Med Video laryngoscope  Comparing video laryngoscope with macintosh laryngoscope for oral endotracheal intubation in patients undergoing non emergency surgeries. Duration of therapy:1 year 
Comparator Agent  Macintosh Laryngoscope  Comparing video laryngoscope with macintosh laryngoscope for oral endotracheal intubation in patients undergoing non emergency surgeries. Duration of therapy : 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) American society of anesthesiologist(ASA)
grade I and II
2) Age between 18-60 years of either sex
3) MPG grade I and II
4) Patients requiring tracheal intubation
under general anesthesia
5) BMI 18.5-30
 
 
ExclusionCriteria 
Details  1) Age<18 years and >60 years
2) ASA grade III and IV
3) MPG grade III and IV
4) BMI<18.5 and >30
5) Patient not consenting to be a part of the
study.
 
 
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 evaluate the total intubation time in video laryngoscopy group vs direct laryngoscopy group.  Laryngoscopy using either macintosh laryngoscope or videolaryngoscope will be attempted after 3 minutes of administration of muscle relaxant. 
 
Secondary Outcome  
Outcome  TimePoints 
•To evaluate the number of intubation attempts in video laryngoscopy group vs direct laryngoscopy group.

•To evaluate the time to best laryngoscopic view in video laryngoscopy group vs direct laryngoscopy group. 		 Laryngoscopy using either macintosh laryngoscope or videolaryngoscope will be attempted after 3 minutes of administration of muscle relaxant. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/11/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharmagori786@gmail.com].

  6. For how long will this data be available start date provided 18-11-2022 and end date provided 18-11-2023?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

A comparative evaluation between Huge Med video laryngoscope and macintosh laryngoscope in patients undergoing tracheal intubation under general anesthesia in non emergency surgeries ; a randomized control study to primarily assess the intubation time between the two devices.

 
Close