| CTRI Number |
CTRI/2025/09/095509 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational study to compare the success rate of palpation of cricothyroid membrane in participants with normal and difficult airway based on neck parameters. |
|
Scientific Title of Study
|
Evaluation of Digital Palpation method for identification of Cricothyroid membrane in normal and Anticipated difficult airway patients |
| 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 TANISHQ KURL |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung Hospital , Ansari nagar east, New Delhi
Department of anaesthesia and intensive care , VMMC and Safdarjung Hospital , Ansari nagar east, New Delhi
South
DELHI
110029
India |
| Phone |
9971153129 |
| Fax |
|
| Email |
tanishqkurl600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANJALI KOCHHAR |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung Hospital , Ansari nagar east, New Delhi
South
DELHI
110029
India |
| Phone |
9999197721 |
| Fax |
|
| Email |
dranjalikochhar@vmmc-sjh.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANJALI KOCHHAR |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care , VMMC and Safdarjung Hospital , Ansari nagar east, New Delhi
South
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 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital Ansari nagar east, New Delhi, 110029 |
| 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 |
| Dr TANISHQ KURL |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesia and intensive care , VMMC and Safdarjung Hospital , Ansari nagar east, New Delhi
South
DELHI |
9971153129
tanishqkurl600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2 planned for elective surgery with normal and anticipated difficult airway as predicted by modified mallampati grade and neck parameters ( neck circumference. Thyromental distance , ratio of neck circumference to thyroid tail distance) |
|
| ExclusionCriteria |
| Details |
Difficult airway - restricted mouth opening, immobility of cervical spine, temporomandibular joint ankylosis.
Patients with neck swelling ( thyroid, midline mass, scars, Contractures)
Patients unable to lie supine or perform head extension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of digital palpation method for identification of cricothyroid membrane in normal and anticipated difficult airway patients by measuring its success in terms of absolute distance between digital palpation point and ultrasound point. |
1 hour preoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of digital palpation method for identification of cricothyroid membrane in normal and anticipated difficult airway patients by measuring its success in terms of absolute distance between digital palpation point and ultrasound point and its correlation with -
1. Gender and body mass index of patient
2. Airway parameters ( modified Mallampati grade, neck circumference, thyromental distance ) |
1 hour preoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/10/2025 |
| 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) |
Open to Recruitment |
|
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 is a prospective cross-sectional observation study to evaluate the success rate of digital palpation method for identification of cricothyroid membrane in patients with normal and anticipated difficult airway patients.
The success of digital palpation is defined when the point marked by digital palpation is within 5mm of point marked by ultrasound. Also the distance between these two points will be measured. This success rate and distance will be correlated with various airway factors (Modified Mallampati grade, neck circumference , thyromental distance ) and demographic factors ( age , gender, BMI ). |