| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
|
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. |