| CTRI Number |
CTRI/2025/02/080609 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare Thyromental Height Test with Thyromental distance in predicting difficult intubation in cardiac surgical patients |
|
Scientific Title of Study
|
Comparison of Thyromental Height Test with Thyromental distance as predictor of difficult intubation in cardiac surgical patients - CROSS SECTIONAL COMPARATIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Upadhyay |
| Designation |
Junior Resident |
| Affiliation |
Mgm Medical College And Hospital |
| Address |
Department of Anesthesia, MGM Medical College and Hospital,
N-6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9695919284 |
| Fax |
|
| Email |
snehalupadhyay25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AJITA ANNACHHATRE |
| Designation |
Associate Professor, Department of Cardiac Anesthesia |
| Affiliation |
Mgm Medical College And Hospital Aurangabad |
| Address |
CVTS OT, MGM Medical College and Hospital, N-6 Cidco, Aurangabad
MGM Medical College and Hospital
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9011672130 |
| Fax |
|
| Email |
sannachhatre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AJITA ANNACHHATRE |
| Designation |
Associate Professor, Department of Anesthesia |
| Affiliation |
Mgm Medical College And Hospital Aurangabad |
| Address |
MGM Medical College and Hospital, N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9011672130 |
| Fax |
|
| Email |
sannachhatre@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital, N-6 Cidco, Aurangabad 430010 , Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital Aurangabad |
| Address |
MGM Medical College and Hospital, N-6 Cidco, Aurangabad |
| 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 SNEHAL UPADHYAY |
CVTS OT, Mgm Medical College And Hospital Aurangabad |
CVTS OT,1st floor, MGM Medical College and Hospital, N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA |
9695919284
snehalupadhyay25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMS ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective cardiac surgeries
2. Both Male and Female
3. Age group: 18 to 65 years old |
|
| ExclusionCriteria |
| Details |
1. Body mass index > 30kg/metre square
2. Craniofacial malformations
3. Abnormal dentition
4. Unable to sit
5. Decreased mouth opening <2.5cm
6. Restricted neck extension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study sensitivity and specificity of thyromental height test in difficult intubation
2. To study sensitivity and specificity of thyromental Distance in difficult intubation |
to measure thyromental height and distance prior to intubation and comparing difficulty level after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study positive predictive value and negative predictive value of thyromental height test in difficult
intubation
2.To study positive predictive value and negative predictive value of thyromental distance in difficult
intubation
|
measure thyromental height and thyromental distance before intubation and comparing accurancy thereafter intubation |
|
|
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)
|
25/02/2025 |
| 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
|
Anaesthesia has developed a lot in recent years but failure to secure the airway remains the most dangerous situation. There can be several complications ranging from sorethroat to cerebral damage and death,due to maintain patent airway after induction.
There are varous tests used to predict difficult intubation as Thyromental distance , Mallampatti score , inter incisor gap, ability to prognath, but there is no single test that has been shown to predict difficult intubation reliably.
Recently a Newer Test Thyromental Height Test has been introduced to predict difficult intubation.
The Thyromental Height Test is The height between anterior border of mentum and thyroid cartilage, while patient lies supine with his/her mouOur study is designed to assess the validity of Thyromental Height Test as a single objective measure for predicting difficult intubation and its comparison with Thyromental Distance
|