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CTRI Number  CTRI/2026/01/100331 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Using Ultrasound and Mouth Opening Assessment to Predict Difficult Airway During Anaesthesia: A Hospital-Based Study in Eastern India 
Scientific Title of Study   Comparison of Ultrasonography-Guided Skin-to-Epiglottis Distance and Mallampati Score for Prediction of Difficult Airway in a Tertiary Care Hospital in Eastern India: 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  Kumari Sneha 
Designation  Associate Professor 
Affiliation  AIIMS Kalyani 
Address  department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal

Nadia
WEST BENGAL
741245
India 
Phone  09818234861  
Fax    
Email  kumari.anesth@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Kumari Sneha 
Designation  Associate Professor 
Affiliation  AIIMS Kalyani 
Address  department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal


WEST BENGAL
741245
India 
Phone  09818234861  
Fax    
Email  kumari.anesth@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kumari Sneha 
Designation  Associate Professor 
Affiliation  AIIMS Kalyani 
Address  department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal


WEST BENGAL
741245
India 
Phone  09818234861  
Fax    
Email  kumari.anesth@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
aiims kalyani 
 
Primary Sponsor  
Name  AIIMS Kalyani 
Address  DEPARTMENT OF ANAESTHESIA IPD BUILDING,FIRST FLOOR,SAGUNA,NH-34 CONNECTOR,BASANTPUR,KALYANI,WEST BENGAL ,741245 
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 
Kumari Sneha  Operation theatre  department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal
Nadia
WEST BENGAL 
09818234861

kumari.anesth@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS KALYANI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undergoing elective surgery under general anaesthesia 
 
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 classified as ASA I or II. scheduled for elective surgeries requiring general anesthesia and endotracheal intubation. who provide informed, written consent.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the predictive accuracy of ultrasonographic skin-to-epiglottis distance and Mallampati score for difficult laryngoscopy  not applied 
 
Secondary Outcome  
Outcome  TimePoints 
determine the sensitivity, specificity, positive predictive value (PPV), & negative To predictive value (NPV) of both methods  Not Applied 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/02/2027 
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="0"
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  

This study focuses on predicting difficult airway during general anesthesia, which is an important concern for patient safety. Difficulty in visualizing the vocal cords during laryngoscopy can lead to serious complications such as low oxygen levels airway trauma and even life threatening situations. Therefore accurate preoperative airway assessment is essential.

Traditionally the Modified Mallampati score is used to assess airway difficulty by examining mouth opening and visibility of oral structures. However this method is subjective and its accuracy is variable. Recent advances in ultrasound technology have made it possible to assess airway anatomy in a simple non invasive and real time manner. One such ultrasound parameter is the skin to epiglottis distance which measures the depth of airway structures and may help predict difficult laryngoscopy more reliably.

This prospective observational study will be conducted at AIIMS Kalyani over a period of six months. Adult patients aged 18 to 65 years belonging to ASA physical status I or II and scheduled for elective surgery under general anesthesia will be included after informed consent. Patients with known airway problems emergency surgeries pregnant patients or cervical spine instability will be excluded.

Before surgery all patients will undergo routine airway assessment using the Modified Mallampati score. Ultrasound examination of the airway will then be performed in the supine position to measure the skin to epiglottis distance. During anesthesia laryngoscopy will be carried out by an experienced anesthesiologist and the view will be graded. Difficult laryngoscopy will be defined as poor laryngeal view.

The main outcome of the study is to compare the accuracy of ultrasound measured skin to epiglottis distance with the Mallampati score in predicting difficult laryngoscopy. Secondary outcomes include assessment of sensitivity specificity positive predictive value and negative predictive value of both methods.

The results of this study may help improve preoperative airway assessment and enhance patient safety by reducing unexpected difficult airway situations in anesthesia practice.

 
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