| CTRI Number |
CTRI/2025/07/091250 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study comparing two methods (using persons height with two different neck measurements)to see which one better predicts if a patient might have a difficult airway during planned surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of the diagnostic values of height to hyomental distance ratio and height to thyromental distance ratio in predicting difficult airway in adult patients posted for general anaesthesia |
| 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 Harikrishnan B |
| Designation |
MD Post graduate |
| Affiliation |
Esic medical college and hospital |
| Address |
33 kittanki street
Kamuthi
Ramanathapuram district
Department of anaesthesia
B block
1st floor
Esic medical college and hospital, 10 Ashok pillar main road, kk nagar, Chennai-600078
Chennai
TAMIL NADU
623603
India |
| Phone |
9597202303 |
| Fax |
|
| Email |
hari79865@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sundaram L N |
| Designation |
Associate professor |
| Affiliation |
Esic medical college and hospital |
| Address |
Department of anaesthesia
B block, 1st floor
Esic medical college and hospital
10 Ashok pillar main road
Kk nagar, Chennai 600078
10 ashok pilar main road
Kk nagar
Chennai -600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9600614533 |
| Fax |
|
| Email |
sun_gallant@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premkumar D |
| Designation |
Assistant professor |
| Affiliation |
Esic medical college and hospital |
| Address |
Department of anaesthesia
B block, 1st floor
Esic medical college and hospital
10 ashok pillar main road
Kk nagar Chennai
10 ashok pillar main road
Kk nagar
Chennai -600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9566220405 |
| Fax |
|
| Email |
doc.premkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Esic medical college and hospital , kk nagar,Chennai 600078 |
|
|
Primary Sponsor
|
| Name |
Esic medical college and hospital |
| Address |
Kk nagar
Chennai 600078 |
| 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 Harikrishnan B |
ESIC medical college and hospital |
Department of anaesthesia
1st floor
B block
Chennai
TAMIL NADU |
9597202303
hari79865@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, esic medical college and hospital, kk nagar |
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 |
| Intervention |
Hyomental distance |
Under ultrasound guidance,the distance is measured from bony point of mentum to hyoid bone with head in extension and mouth closed |
| Comparator Agent |
Thyromental distance |
Under ultrasound guidance, the distance is measured from the bony point of mentum to thyroid cartilage with head in extension and mouth closed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA 1,2 and 3
18-70years of both the sexes
Patient posted for elective surgeries under general anaesthesia
BMI UPTO 40
|
|
| ExclusionCriteria |
| Details |
Major airway abnormalities
Restricted Neck mobility
Neck tumours
Post burn contractures
Pregnancy
Kyphoscoliosis
BMI of more than 40
and those requiring rapis sequence intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of the better predictor either TMD Or HMD is expected to demonstrate higher predictive accuracy for difficult laryngoscopy as shown by -greater sensitivity,specificity and higher the area under the curve |
30minutes before intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
01/08/2025 |
| 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) |
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
|
A prospective observational study which includes patient posted for elective surgeries under general anaesthesia aims to identify the better predictor of difficult laryngoscopy between hyomental and thyromental distance. These distances are measured under USG guidance. Calculating the ratio of patient height to hyomental distance and patient height to thyromental distance and comparing with gold standard cormack lehane grading. Finding the sensitivity,specificity, ppv and npv for each ratio and plotting the receiver operator curve which tells about the area under the curve. Higher the sensitivity & specificity , greater the area under the curve better predictor it will be.All the enrolled patients underwent a thorough preoperative evaluation including a detailed history and clinical examination and advised standard operative fasting guidelines.Lab Investigations, chest X ray, ECG were assessed relevant to the patient and surgical requirements.HMD is measured from the distance between bony point of mentum to hyoid bone with head in extension and mouth closed.TMD is measured under bony point of mentum to thyroid cartilage with head in extension and mouth closed.Airway assessment was done by a single anesthesiologist in all cases who would not participate in endotracheal intubation. Difficult airway carts with bougie,styles,video laryngoscope, laryngeal ask airways and fibreoptic bronchoscopeof appropriate sizes are made available in the operating room. |