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CTRI Number  CTRI/2021/08/035636 [Registered on: 13/08/2021] Trial Registered Prospectively
Last Modified On: 06/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   diagnostic 
Study Design  Other 
Public Title of Study   The study involves which method better identify the difficulty in laryngoscopy during general anaesthesia, whether ultrasound guided measurements of anterior neck or clinically examined method of modified mallampati score. 
Scientific Title of Study   ultrasound measurement of anterior neck soft tissue and tongue thickness in comparison to modified mallampati score to predict difficult laryngoscopy.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C Rajalakshmy alias arthi 
Designation  M.D. Postgratuate 
Affiliation  ESIC Medical college and PGIMSR 
Address  DEPARTMENT OF ANAESTHESIOLOGY, ESIC MEDICAL COLLEGE AND PGIMSR, K.K. NAGAR, CHENNAI.
K.K.Nagar, Chennai.
Chennai
TAMIL NADU
600078
India 
Phone  9159738948  
Fax    
Email  rajalakshmyarthi71@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K RADHIKA 
Designation  PROFESSOR in Anaesthesiology 
Affiliation  ESIC Medical college and PGIMSR 
Address  DEPARTMENT OF ANAESTHESIOLOGY, ESIC MEDICAL COLLEGE AND PGIMSR, K.K. NAGAR, CHENNAI.
K.K.Nagar, Chennai.
Chennai
TAMIL NADU
600078
India 
Phone  9159738948  
Fax    
Email  radhikamurali0095@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr CRajalakshmy alias arthi 
Designation  M.D. Postgratuate 
Affiliation  ESIC Medical college and PGIMSR 
Address  department of anaesthesia, ESIC medical college and PGIMSR, K.K. Nagar, chennai
K.K.Nagar, Chennai.
Chennai
TAMIL NADU
600078
India 
Phone  9159738948  
Fax    
Email  rajalakshmyarthi71@gmail.com  
 
Source of Monetary or Material Support  
ESIC MEDICAL COLLEGE AND PGIMSR, CHENNAI 
 
Primary Sponsor  
Name  Dr C Rajalakshmy arthi 
Address  ESIC MEDICAL COLLEGE AND HOSPITAL, K.K.NAGAR, CHENNAI-600078 
Type of Sponsor  Other [self] 
 
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 
DrCRajalskshmy alias arthi  ESIC MEDICAL COLLEGE  DEPARTMENT OF ANAESTHESIOLOGY, K.K. NAGAR.
Chennai
TAMIL NADU 		 9159738948

rajalakshmyarthi71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ESIC MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V00-Y99||External causes of morbidity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients posted for elective surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  Emergency surgeries, pregnant women, cervical instability, edentulous patients, the interincisor gap less than 3 cm, patients with altered level of consciousness, patients with head and neck pathologies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ulrasound measurement of anterior neck soft tissue have greater sensitivity and specificity than modified mallampatti score in predicting difficult laryngoscopy  1 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
Ultrasound measurements of anterior neck soft tissue can alone detect difficult laryngoscopy  1 WEEK 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   15/08/2021 
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="0"
Months="9"
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-identiļ¬cation.

  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 - 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 (Others) -  WILL BE AVAILABLE AS RECORD IN THE DEPARTMENT

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 01-04-2028?
    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 - NIL
Brief Summary   The study involves comparison of ultrasound measurement of anterior neck soft tissue at the levels of hyoid bone, thyromental distance and tongue thickness with modified mallampati score which is a clinically used accepted method commonly used. 
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