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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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