| CTRI Number |
CTRI/2025/10/096033 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of measurements in mouth using ultrasound placed over neck to predict difficult mask ventilation and difficult laryngoscopy and intubation in obese patients. |
|
Scientific Title of Study
|
Ultrasonographic evaluation of palatoglossal space and other airway parameters in prediction of difficult mask ventilation and difficult laryngoscopy- intubation in obese patients: 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 |
Swati Chhabra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, D and T Block Third floor, All India Institute of Medical Sciences
Basni Phase2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07340033034 |
| Fax |
|
| Email |
swati_virgo83@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Chhabra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, D and T Block Third floor, All India Institute of Medical Sciences
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07340033034 |
| Fax |
|
| Email |
swati_virgo83@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SHIVANI N N |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, D and T Block Third floor, All India Institute of Medical Sciences
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08300945010 |
| Fax |
|
| Email |
122.n.n.shivani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur Basini Phase 2 Jodhpur 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Basni Phase 2, Jodhpur 342005 Rajasthan, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Swati Chhabra |
All India Institute of Medical Sciences Jodhpur |
D and T OT complex Department of Anaesthesiology and Critical Care
Jodhpur
RAJASTHAN |
07340033034
swati_virgo83@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult obese patients posted for elective surgery under general anaesthesia with planned laryngoscopy and tracheal intubation.
|
|
| ExclusionCriteria |
| Details |
Patients with a previous history of major airway surgery or airway pathology, cervical spine surgery/disease or radiation therapy.
Pregnant patients
Patients already intubated or tracheostomized
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine the sensitivity and specificity of palatoglossal space in predicting difficult mask ventilation in obese patients.
|
T0: Assessment of Airway with Ultrasound
T1: Assessment of mask Ventilation at Induction of General Anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Determine the specificity & sensitivity of Tongue thickness (TT), tongue width (TW), tongue volume (TV) & cross sectional area of tongue (TCSA) in predicting difficult mask ventilation .
Determine the specificity & sensitivity of hyomental distance in neutral (HMDN) & extended (HMDE) head position & their ratio (HMDR), hyoid bone visibility on sublingual scan, Anterior neck soft tissue thickness at the level of epiglottis (SED), hyoid (SHD), vocal cords (SVC) & distance from skin to epiglottis (pre-E) & epiglottis to mid point of vocal cord (E-VC) & their ratio (pre-E/E-VC) in predicting difficult laryngoscopy & intubation.
|
T0: Assessment of Airway with Ultrasound
T1: Assessment of mask Ventilation at Induction of General Anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
01/11/2025 |
| 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 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
|
Aims and Objectives: The aim of the present study is to evaluate the diagnostic efficacy of sonographic measures in predicting DMV and difficult laryngoscopy. Primary objective: Determine the sensitivity and specificity of palatoglossal space in predicting difficult mask ventilation in obese patients. Secondary objectives: Determine the specificity and sensitivity of Tongue thickness (TT), tongue width (TW), tongue volume (TV) and cross sectional area of tongue (TCSA) in predicting difficult mask ventilation . Determine the specificity and sensitivity of hyomental distance in neutral (HMDN) and extended (HMDE) head position and their ratio (HMDR), hyoid bone visibility on sublingual scan, Anterior neck soft tissue thickness at the level of epiglottis (SED), hyoid (SHD), vocal cords (SVC) and distance from skin to epiglottis (pre-E) and epiglottis to mid point of vocal cord (E-VC) and their ratio (pre-E/E-VC) in predicting difficult laryngoscopy and intubation. Inclusion criteria: All adult obese patients (BMI>30) posted for elective surgery under general anaesthesia with planned laryngoscopy and tracheal intubation. Exclusion criteria: Patients with a previous history of major airway surgery or airway pathology, cervical spine surgery/disease or radiation therapy. Pregnant patients Patients already intubated or tracheostomized
|