FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/08/035764 [Registered on: 18/08/2021] Trial Registered Prospectively
Last Modified On: 09/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   LARYNGEAL VIEW USING CONVENTIONAL LARYNGOSCOPE AND VIDEO LARYNGOSCOPE IN ADULT PATIENTS  
Scientific Title of Study   Comparison of laryngeal view using conventional laryngoscope with video laryngoscope and its association with modified mallampati score in adult patients 
Trial Acronym  COLV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parul Tanwar 
Designation  Postgraduate 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Ground Floor Main OT building Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  9643128917  
Fax    
Email  parultanwar95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Panwar 
Designation  Associate Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department Of Anaesthesia And Intensive Care Ground Floor Main OT Building Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  9013000543  
Fax    
Email  drmkumath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parul Tanwar 
Designation  Postgraduate 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department Of Anaesthesia And Intensive Care Ground Floor Main OT Building Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  9643128917  
Fax    
Email  parultanwar95@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesia And Intensive Care Ground Floor Main OT Building Safdarjung Hospital New Delhi 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department Of Anaesthesia And Intensive Care Ground Floor Main OT Building Safdarjung Hospital New Delhi 110029 
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 
Dr Parul Tanwar  Vardhman Mahavir Medical College and Safdarjung Hospital  Department Of Anaesthesia And Intensive Care Ground Floor Main OT Building Safdarjung Hospital New Delhi
South
DELHI 		 9643128917

parultanwar95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VMMC And Safdarjung Hospital, New Delhi -110029   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  nil   this is an observational cohort study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery requiring intubation
American society of anesthesiology grade I-II
Patients with ability to sit and open their mouth
 
 
ExclusionCriteria 
Details  PREGNANCY
PRESENCE OF AIRWAY PATHOLOGY(INFECTIOUS/NEOPLASTIC)
PATIENTS WITH HISTORY OF BURNS OR TRAUMA TO AIRWAY
PATIENTS WITH RESTRICTED MOBILITY OF NECK AND MANDIBLE
ALL PATIENTS WITH UNSTABLE CERVICAL SPINE  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the laryngeal view (Cormack and Lehane grading) by conventional laryngoscopy and video laryngoscopy using C-MAC video laryngoscope, in adults undergoing surgery and comparing it with preoperatively assessed Modified Mallampati score  72 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the conventional laryngoscopy with that of video laryngoscopy using C-MAC video laryngoscope for endotracheal intubation in adults undergoing surgery in terms of:
time taken to achieve best glottic view,
Number of maneuvers used,
Time taken for intubation
 		 72 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   20/08/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [parultanwar95@gmail.com].

  6. For how long will this data be available start date provided 20-05-2021 and end date provided 20-05-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - parultanwar95@gmail.com
Brief Summary  

 This is a prospective observational comparative study to compare  laryngeal view using conventional laryngoscopy with video laryngoscopy and its association with Modified Mallampati score in adult patient undergoing elective surgeries with primary objective of comparing laryngeal view using Cormack and Lehane grading and secondary objective of comparing time taken to achieve best glottic view , number of maneuvers used and time taken for intubation.

 


 
Close