| CTRI Number |
CTRI/2024/02/062791 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is intended to compare thyromental height test with other conventional methods for predicting difficult laryngoscopy at SMS Medical College , Jaipur. |
|
Scientific Title of Study
|
A prospective observational study to compare thyromental height test with ratio of height to thyromental distance,thyromental distance and modified mallampati test in predicting difficult laryngoscopy 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 Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department Of Anaesthesiology,
Sawai Man Singh Medical College and Attached Hospitals,Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
drkanchan2371@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
Sawai Man SinghMedical College And Attached Hospitals |
| Address |
Department Of Anaesthesiology,
Sawai Man Singh Medical College and Attached Hospitals,Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
drkanchan2371@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma Kuriakose |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department Of Anaesthesiology,
Sawai Man Singh Medical College and Attached Hospitals,Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9497615357 |
| Fax |
|
| Email |
reshmakuriakose1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology,SMS Medical College and Attached Hospitals |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology,SMS Medical College and Attached Hospitals |
| Address |
JLN Marg ,Adarsh Nagar ,Jaipur
pin: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 RESHMA KURIAKOSE |
SMS Medical College and Attached Hospitals |
Department of Anaesthesiology,
Second Floor,
Dhanwantari Building,
SMS Medical College and Attached Hospitals,JLN Marg,Adarsh Nagar,Jaipur
Rajasthan
Jaipur
RAJASTHAN |
9497615357
reshmakuriakose1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS |
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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled to undergo elective surgical procedures under general anesthesia and endotracheal intubation willing to give informed written consent
BMI 18.5 – 24.9 Kg/m2
ASA grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Edentulous patients
Patients with BMI >30
Patients with inability to open the mouth
Patients with upper airway and neck pathologies and cervical spine pathology
Pregnant patients
Patients requiring rapid sequence induction of anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Thyromental distance(TMD)
2. Thyromental height
3. Ratio of Height to Thyromental distance(RHTMD)
4. Modified Mallampati test(MMT)
|
During Pre-Anaesthetic Checkup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="447"
Sample Size from India="447"
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)
|
29/02/2024 |
| 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="0"
Months="3"
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
|
In this study our aim is to evaluate the diagnostic accuracy of Thyromental height test (TMHT)and to compare it with the established airway predictors, ratio of height to thyromental distance (RHTMD), thyromental distance (TMD), and modified Mallampati test (MMT) in predicting difficult laryngoscopy in patients undergoing elective surgical procedures under general anaesthesia and endotracheal intubation. |