| CTRI Number |
CTRI/2025/11/098140 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identify difficult intubation by measuring height and distance. |
|
Scientific Title of Study
|
A comparative study to predict difficult intubation by measuring the ratio of height to thyromental distance versus height to sternomental distance, at SMS Medical College, Jaipur |
| 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. RAJEEV SHARMA |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLEGE JAIPUR |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building, JLN marg jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829088926 |
| Fax |
|
| Email |
sharma.rajeev0911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. RAJEEV SHARMA |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLEGE JAIPUR |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building, JLN marg jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829088926 |
| Fax |
|
| Email |
sharma.rajeev0911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. GOPESH KUMAR |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building, JLN marg jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7742444952 |
| Fax |
|
| Email |
gopesh077@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS medical college,
Adarsh Nagar, Jaipur, rajsthan, india
302004 |
|
|
Primary Sponsor
|
| Name |
Sawaiman Singh Medical College And Hospital |
| Address |
Department of Anaesthesiology, Second floor, dhanvantri building, JLN marg , jaipur , rajsthan, india 302004 |
| 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 Gopesh Kumar |
Sawaiman Singh Medical College And Hospitals, jaipur |
Plastic ot, Second floor, Dhanvantri building, JLN marg
302004
Jaipur
RAJASTHAN |
7742444952
gopesh077@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of ethics comittee, sms medical caollege and attached hospitals, jaipur |
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
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient undergoing intubation.
2) Patient age 18-60 years either of sex.
3) Able to comply with test.
4) Patient giving written and informed consent |
|
| ExclusionCriteria |
| Details |
1) Emergency case.
2) Recent oral or Maxillofacial surgery.
3) Midline neck swelling.
4) Known cardio-respiratory compromise.
5) Mouth opening less than 3 cm.
6) Pregnant patients.
7) Temporomandibular joint ankylosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean of Ratio of height to thyromental distance
Mean of Ratio of height to sternomental distance
Mean of Cormack Lehane Grade |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
08/12/2025 |
| 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
|
patient arrival in OT Name, fasting status, written and informed consent and PAC will be checked Height, thyromental distance and sternomental distance measure and calculate RHTMD and RHSMD Monitoring of patient started using pulse oximeter and ECG iv line secured After preoxyganation with 100% oxygen, premedication and induction agent given After laryngoscopy CL grade noted and intubation will be done Data will be collected - Ratio of hieght to thyromental distance
- Ratio of height to sternomental distane
- Cormack lehane grade
|