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CTRI Number  CTRI/2025/07/090852 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Use of ultrasound to measure airway structures for predicting difficult laryngoscopy in patients undergoing surgery 
Scientific Title of Study   Evaluation of skin to epiglottis distance, tongue thickness and hyomental distance by airway ultrasound for predicting difficult laryngoscopy: A prospective observational study.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhumika Gautam 
Designation  PGJR1 
Affiliation  Government Institute of Medical Sciences, Greater Noida 
Address  Department of Anesthesia, First floor, Ot complex, Government Institute of Medical Sciences, Kasna, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone  9045441801  
Fax    
Email  bhumikagautam123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nazia Nazir  
Designation  Professor & Head 
Affiliation  Government Institute of Medical Sciences, Greater Noida 
Address  Department of Anesthesia, First floor, Room no.2046, Ot complex, Government Institute of Medical Sciences, Kasna, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9560102957  
Fax    
Email  nazunazir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhumika Gautam 
Designation  PGJR1 
Affiliation  Government Institute of Medical Sciences, Greater Noida 
Address  Department of Anesthesia, First floor, Ot complex, Government Institute of Medical Sciences, Kasna, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone  9045441801  
Fax    
Email  bhumikagautam123@gmail.com  
 
Source of Monetary or Material Support  
Government Institute of Medical Sciences, near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh, 201310, India. 
 
Primary Sponsor  
Name  Government Institute of Medical Sciences 
Address  Near Gautam Buddha University, kasna village, Greater Noida, Uttar Pradesh, 201310, India.  
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 Bhumika Gautam  Government Institute Of Medical Sciences  Near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH 
9045441801

bhumikagautam123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIMS 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  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults aged 18-60 years, classified as ASA I,II,III scheduled for elective surgeries under general anaesthesia that require endotracheal intubation  
 
ExclusionCriteria 
Details  Those posted for emergency surgeries
Patients with airway abnormalities, airway trauma, or conditions like retrognathis, macroglossia or beard that could interfere with airway assessment
Neck scarring, swelling, burns, limited neck mobility, or a history of neck surgery
Those not providing written informed consent and other concurrent conditions such as cervical spine trauma, thyroid goitre, tracheal stenosis etc 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the predictive value of airway ultrasound measurements (combination of skin to epiglottis distance, tongue thickness and hyomental distance) for difficult laryngoscopy with Cormack-Lehane grading.
 
5mins, 10 mins, 20mins, 30mins 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the predictive value of airway ultrasound measurements with traditional
clinical parameters (modified Mallampati grading, neck circumference and hyomental
distance) for difficult laryngoscopy with Cormack-Lehane grading. 
5 mins, 10 mins, 20 mins, 30 mins 
To compare the predictive value of airway ultrasound measurements with traditional
clinical parameters (modified Mallampati grading, neck circumference and hyomental
distance) for difficult laryngoscopy with Cormack-Lehane grading. 
5 mins, 10 mins, 20 mins, 30 mins 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   01/08/2025 
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 Yet Recruiting 
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  
The primary responsibility of the anesthesiologist is to provide adequate oxygenation and
ventilation to the patient by securing the airway. 1

An unanticipated situation of “Cannot Intubate Cannot Oxygenate” is most dreaded among
the anesthesiologists. These events mainly pertain to failure of maintaining patent airway.
To prevent such untoward events, many methods have been introduced to identify who can
be easily intubated or not. 2

Difficulty in airway management is a significant cause of morbidity and mortality in
anesthesia, intensive care, and emergency medicine practice. Recognizing patients at risk of
difficult tracheal intubation is essential, especially in patients with apparently normallooking
airways. Difficult laryngoscopy (DL) is considered a surrogate indicator of difficult
intubation. 3

However, every once in a while, an anesthesiologist encounters an unanticipated difficult
intubation, which leads to stressful clinical situations, especially in resourcepoor
highvolume centres. The incidence of DL ranges between 1.5 and 13%, and the primary
goal of the anesthesiologists is to recognize the difficult airway (DA) and to reduce or
eliminate potential risks linked to its precise management. 3

Ultrasound has also emerged as a promising tool for airway assessment and management
due to its familiarity, accessibility, safety, and non-invasive nature. It can assist physicians
in identifying relevant anatomy with objective measurements of airway parameters and
guiding airway interventions with dynamic real-time images. 4

This study aims to ultrasonographically assess the soft tissue thickness preoperatively based
on three parameters-skin to epiglottis distance, tongue thickness and hyomental distance and
find out whether these parameters can predict a difficult airway in adults.
 
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