CTRI Number |
CTRI/2022/10/046850 [Registered on: 27/10/2022] Trial Registered Prospectively |
Last Modified On: |
10/10/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Identification Of Difficulty In Inserting A Tube Into Breathing System By Using Different Tests Before Operation In Children Undergoing Surgery |
Scientific Title of Study
|
Comparative Evaluation Of Pre-Anaesthetic Clinical Tests For Predicting Difficult Airway In Children Of 6-12 Years Of Age Undergoing Elective Surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
CHETAN K B |
Designation |
Post Graduate Student |
Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Address |
Vardhman Mahavir Medical College And Safdarjung Hospital
Ansari Nagar New Delhi
South DELHI 110029 India |
Phone |
7019217620 |
Fax |
|
Email |
chetankbc2@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
G USHA |
Designation |
Consultant And Professor |
Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Address |
Vardhman Mahavir Medical College And Safdarjung Hospital
Ansari Nagar New Delhi
South DELHI 110029 India |
Phone |
7019217620 |
Fax |
|
Email |
doctorgusha@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
CHETAN K B |
Designation |
Post Graduate Student |
Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Address |
Vardhman Mahavir Medical College And Safdarjung Hospital
Ansari Nagar New Delhi
DELHI 110029 India |
Phone |
7019217620 |
Fax |
|
Email |
chetankbc2@gmail.com |
|
Source of Monetary or Material Support
|
Vardhman Mahavir Medical College And Safdarjung Hospital |
|
Primary Sponsor
|
Name |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Address |
Vardhman Mahavir Medical College And Safdarjung Hospital
Ansari Nagar New Delhi |
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 |
CHETAN K B |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Department Of Anaesthesia Pre Anaesthetic Checkup Clinic South DELHI |
07019217620
chetankbc2@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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
|
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
ASA Grade I And II Patients,
Age group: 6-12 Years Of Age,
Both Genders,
Children Posted For Elective Surgery
|
|
ExclusionCriteria |
Details |
Children with congenital defects or syndromes involving upper airway,
Patients with known difficult upper airway, lesion/ growth in head and neck,
Children with Obstructive Sleep Apnoea,
Uncooperative children
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare pre-anaesthetic clinical tests for predicting difficult airway in children between 6-12 years of age undergoing elective surgery |
To compare pre-anaesthetic clinical tests for predicting difficult airway in children between 6-12 years of age undergoing elective surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate predictive value of each of the tests for predicting difficulty airway.
To find single test with maximum predictive value for assessing difficulty airway.
|
compared with CL grading during laryngoscopy thst is periopertaive period |
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
01/11/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
01/11/2022 |
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)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In adult patients,
various predictive tests for difficult airway are used. The modified Mallampati
test (MMT) is a simple airway assessment tool to predict difficult intubation
from the anatomy of oropharynx. Other bedside tests like Thyromental distance (TMD), Ratio
of height to thyromental distance (RHTMD), Mandible Protrusion Test (MPT), Modified measurement
of Sterno-mental distance are routinely used to evaluate difficult intubation
in adults. The use of various preoperative airway assessment parameters for
predicting difficult intubation in adults has been established in the
literature. However, unlike adults, there are no defined parameters in the
paediatric population that can help predict and recognize paediatric patients
who are at risk of difficult intubation. These tests have different sensitivity
and specificity in predicting difficult airway. It is not clear,
which method is better than others for prediction of difficult laryngoscopy.
In view of above situation, we are conducting a
study to compare the predictive value of various tests for predicting difficult
laryngoscopy in children aged between 6 – 12 years who are posted for elective
surgery. |