| CTRI Number |
CTRI/2025/10/096094 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound measurements of neck distance HMD ans SHB to find out difficult airway before elective and emergency surgery |
|
Scientific Title of Study
|
Predicting Difficult Airways by using ultrasound parameters in adult patients undergoing general anesthesia |
| 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 Sakshi gupta |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Anaesthesia Rohilkhand medical college and hospital Pilibhit bypass road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8394860796 |
| Fax |
|
| Email |
dr.sakshi100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Khalik |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
645 faiq enclave phase 2 Pilibhit bypass road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9639568399 |
| Fax |
|
| Email |
ansarikhalik786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawna singh |
| Designation |
Assistant professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room no 503 Tower building Rohilkhand medical college and hospital Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
6392763047 |
| Fax |
|
| Email |
sbhavi06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital Pilibhit bypass road uttar pradesh India 243006 |
|
|
Primary Sponsor
|
| Name |
DR Sakshi gupta |
| Address |
Rohilkhand medical college and hospital Pilibhit bypass road Bareilly uttar pradesh 243006 India |
| Type of Sponsor |
Other [Self] |
|
|
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 Mohd khalik |
Rohilkhand medical college and hospital Bareilly |
Department of anesthesiology Rohilkhand medical college and hospital Pilibhit bypass road Bareilly Uttar Pradesh 243006 India
Bareilly
UTTAR PRADESH |
8218736776
ansarikhalik786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committe rmch barielly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade 1 2 3 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound parameter distance measured Hyomental distance and skin to hyoid bone distance for comparing difficupt airway |
Pateint will be examined in pre op distance will be measured using ultrasound probe and then three measurement will taken out of them average will be marked and will compare with the theoretical parameters given for the distance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1 2 3
Schedule for elective or emergency procedures requiring general anesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Known pre-existing difficult airway
Condition that may distort airway anatomy or ultrasound measurements |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To identify whether Hyomental distance and skin-to-hyoid bone distance measured by ultrasound can serve as reilable predictors of difficult intubation |
In pre operative 3 reading will be taken then out of them average will be marked |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/10/2025 |
| 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="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 evaluates the role of preoperative ultrasound in predicting difficult airways It focuses on measuring specific parameters such as the hyomental distance HMD and the skin-to-hyoid bone distance SHBThe objective is to determine how these ultrasound measurements correlate with laryngoscopic grading |