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CTRI Number  CTRI/2024/01/061940 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Prediction of difficult laryngoscopy by ultrasound measurement of face and neck parameters in adult patients 
Scientific Title of Study   PREDICTION OF DIFFICULT LARYNGOSCOPY BY ULTRASOUND MEASUREMENT OF COMBINATION OF AIRWAY PARAMETERS  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasanth Kumar B 
Designation  Post Graduate Resident  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi India

New Delhi
DELHI
110029
India 
Phone  6382214916  
Fax    
Email  vasanthkumar9023@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anjali Kochhar 
Designation  Associate Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi

New Delhi
DELHI
110029
India 
Phone  9999197721  
Fax    
Email  dranjalikochhar@vmmc-sjh.nic.in  
 
Details of Contact Person
Public Query
 
Name  Anjali Kochhar 
Designation  Associate Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi

New Delhi
DELHI
110029
India 
Phone  9999197721  
Fax    
Email  dranjalikochhar@vmmc-sjh.nic.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  Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,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 
DrVasanth Kumar B  Vardhman Mahavir Medical College and Safdarjung Hospital   Department of anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi
New Delhi
DELHI 
6382214916

vasanthkumar9023@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir Medical College and Safdarjung Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged between 18-65years ,planned for elective surgery under general anaesthesia requiring endotracheal intubation  
 
ExclusionCriteria 
Details  1.Patients with lesions of tongue and restricted mouth opening
2.Neck deformity,restricted neck movement,neck mass,burn neck contracture etc.
3.Anticipated difficult airway with planned awake intubation  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To predict difficult laryngoscopy by ultrasound measurement of combination of airway parameters (hyomental distance ratio,tongue thickness & condylar mobility)using Cormack - Lahane grading  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare, ultrasound measurement of combination of airway parameters (hyomental distance ratio, tongue thickness & condylar mobility)with ultrasound measurement of single parameter of hyomental distance ratio in predicting difficult laryngoscopy.  At the time of induction of anaesthesia 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   26/02/2024 
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="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 the most important component of anaesthesiologist’s pre- operative assessment and is a prerequisite for successful airway management. Repeated attempts to perform laryngoscopy or intubation can lead to lack of adequate oxygen delivery to brain and other vital organs, which can threaten patient life1 and it is the most important cause of anaesthesia related morbidity and mortality.  


The most important factor in successful management of the difficult airway is thorough evaluation and identification of any possible problem. Various clinical parameters determining difficult airway are body mass index, atlanto-occipital extension, temporomandibular joint mobility, hyomental distance, neck mobility, mouth opening and the anatomical location of larynx etc.


The incidence of difficult laryngoscopy and tracheal intubation still ranges between 1.5%-13%.The inability to predict difficult airways is probably due to high inter observer variability and low predictability of commonly used airway assessment screening tests like modified Mallampati test (MMT), thyromental distance (TMD), hyomental distance (HMD) etc.


Hyomental distance is calculated in neutral head position (HMDn) and in extreme of head extension (HMDe). It is taken from anterior most bony landmark palpable on mentum to skin just above the hyoid bone. Hyomental distance ratio (HMDR) is taken as ratio of hyomentaldistance in extreme of head extension (HMDe) to hyomental distance in neutral head position (HMDn). Hyomental distance tell us about the submandibular space and hyomental distance ratio gives us an idea about the capacity to 

extent atlanto-occipital joint, which is required to align oro-pharyngeal and laryngeal axis during direct laryngoscopy.


Tongue thickness (TT)assessed by ultrasound gives us an internal characteristics of patients upper airway and helps us in predicting difficult laryngoscopy


Condylar mobility assessed by ultrasound tells about the adequate mouth opening of the patient which is required for direct laryngoscopy


However ,studies are still insufficient to say that combined ultrasound measurement of hyomental distance ratio,tongue thickness and condylar mobility are the best predictors for difficult laryngoscopy


Ultrasound (USG) being a non- irradiating, non-invasive and simple to use technique is being seen as the best modality for airway evaluation in future. 


Thus ,we planned a study for the prediction of difficult laryngoscopy by ultrasound measurement of combination of airway parameters .



 
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