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CTRI Number  CTRI/2023/09/057406 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 15/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Ultrasonographic assessment of anterior neck for predicting difficult laryngoscopy in adult patients. 
Scientific Title of Study   Ultrasonographic assessment of anterior neck for predicting difficult laryngoscopy in adult patients. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika 
Designation  Post Graduate Resident 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department Of Aaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital

South
DELHI
110029
India 
Phone  9910963099  
Fax    
Email  deepikarana855@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kapil Gupta 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital

South
DELHI
110029
India 
Phone  9811859019  
Fax    
Email  kapgup11@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Kapil Gupta 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital

South
DELHI
110029
India 
Phone  9811859019  
Fax    
Email  kapgup11@yahoo.co.in  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia Vardhman Mahavir Medical College and 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 DEEPIKA  Vardhman Mahavir Medical College And Safdarjung Hospital  Department Of Anaesthesia Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi 110029
South
DELHI 
9910963099

deepikarana855@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Comparator Agent  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery under general anaesthesia requiring Endo-Tracheal Intubation. 
 
ExclusionCriteria 
Details  1.Morbid obesity( BMI>40kg/meter square).
2.Neck deformity, Restricted neck movements, neck mass, neck contracture.
3.Anticipated difficult airway.
4.Pregnancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the role of ultrasonographic assessment of anterior neck structure at the level of epiglottis [Distance from skin to epiglottis (DSE)] in predicting difficult laryngoscopy (Cormack-Lehane grade 3 and 4) in adult patients undergoing elective surgery.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare ultrasonographic measurements of combination of airway parameters (skin to epiglottis distance, skin to hyoid bone distance & skin to vocal cord distance) with clinical measurements in predicting difficult laryngoscopy.  At the time of induction of anaesthesia. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/10/2023 
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="6"
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 - NO
Brief Summary   Airway examination is of prime importance for an anesthesiologist. A patient needing airway management requires assessment for difficult airway. A difficult airway may prohibit mask ventilation or can also lead to repeated failed intubation, this can lead to decrease blood supply to essential organs of body.
Multiple clinical parameters are used to predict difficult airway but incidence of difficult laryngoscopy still ranges between 1.5%-13% probably due to high inter observer differences. Ultrasound is evolving as a useful tool in airway assessment now a days. Ultrasound has several advantages for imaging of the airway - it is safe, quick, repeatable, portable, widely available. 
Patient will be asked to lie supine on a firm surface for ultrasound assessment of anterior neck tissue thickness at the level of hyoid bone, epiglottis and vocal cords using linear probe. Sonographically epiglottis appear as curvilinear, hypoechoic structure with an echogenic pre epiglottic space. Hyoid bone appears as curved echogenic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space. Thyroid cartilage provides the window to view the vocal cords. Vocal cords forms an isosceles triangle with a central tracheal shadow. 
However, not not much research have been done for predicting difficult laryngoscopy using ultrasound. Thus, we are planning to do this study to predict difficult laryngoscopy by using ultrasound and measuring it with clinical parameters.
 
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