| CTRI Number |
CTRI/2025/12/099505 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study that observes to see if the distance between the chin and sternal notch can help predict difficulty in placing a breathing tube in patients undergoing general anesthesia |
|
Scientific Title of Study
|
A prospective observational study to evaluate sternomental displacement as a predictor of difficult airway |
| 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 Pooja Sharma |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Hospital |
| Address |
Department Of Anaesthesia , Second floor , A wing , D Y Patil Hospital , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8108333312 |
| Fax |
|
| Email |
ps7841077@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rochana Bakhshi |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Hospital |
| Address |
Department Of Anaesthesia , Second floor , A wing , D Y Patil Hospital , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9323272151 |
| Fax |
|
| Email |
drrochana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rochana Bakhshi |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Hospital |
| Address |
Department Of Anaesthesia , Second floor , A wing , D Y Patil Hospital , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
MAHARASHTRA
400706
India |
| Phone |
9323272151 |
| Fax |
|
| Email |
drrochana@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Medical College |
| Address |
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Private 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 Pooja Sharma |
Dr D Y Patil Medical College |
Department Of Anaesthesia , Second floor , A wing , D Y Patil Hospital , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA |
8108333312
ps7841077@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health Research (IECBH) of Dr D Y Patil Medical College & Hospital |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Only ASA 1 and ASA 2 patients
2 Patients undergoing general anaesthesia and endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1 Morbidly obese patients
2 Pregnant Patients
3 Patients with cervical spine injury/fixation done in past |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate sternomental displacement with cormack lehane grading of laryngoscopy |
at baseline and 3 minutes after after paralysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the incidence of unanticipated difficult intubation
To evaluate the correlation between Mallampatti classification , upper lip bite test, thyromental distance & inter incisor gap with cormack lehane grading |
at 0 mins baseline & 3 minutes after paralysis |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
13/01/2026 |
| 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="2"
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
|
Endotracheal intubation is a procedure wherein a flexible tube is placed in the trachea in order to maintain an open airway and also a conduit through which certain inhalational agents can be delivered. However, there are certain scenarios in which placing the endotracheal tube can cause difficulty. Problems which may arise due to difficult intubation include hypoxia, aspiration, oesophageal intubation and even cardiac arrest and death. Hence, preoperative assessment plays a crucial role in predicting and managing patients with difficult airway.We need to thoroughly evaluate the airway to avoid last moment inevitable misfortunes. Some of the parameters which could be relatively helpful in assessment of difficult intubation include mouth opening, mallampatti classification (MPC), upper lip bite test (ULBT), thyromental distance (TMD), sternomental displacement (SMD). Sternomental displacement (SMD) will be measured as follows :- SMD in extended position : Patient will be asked to sit comfortably and will be asked to extend his head and neck maximally and the distance between the mentum and the sternal notch will be measured. SMD in neutral position : Patient will be asked to sit comfortably on bed by keeping his head in neutral position and the distance between the mentum and the sternal notch will then be measured. The SMD will be the difference between SMD extended and SMD neutral. A value of less than 5 cm will be considered as a predictor of difficult intubation. A thorough pre op history taking will be done. Patient will be selected based on the inclusion and exclusion criteria. The patient will be explained about the steps involved in the assessment in a language best understood by them and The assessment will be done only if the patient is consenting. The patient will be asked to sit comfortably on the bed and then the following parameters will be checked: 1.Mouth Opening 2.Mallampatti Score 3.Upperlip Bite Test 4.Thyromental Distance 5.sternomental Displacement
|