| CTRI Number |
CTRI/2024/11/076450 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assesment difficult airway intubation using different airway assessment parameters in pediatrics population age group 2 to 10 years |
|
Scientific Title of Study
|
An Observational Study for prediction of difficult intubation using different airway assessment parameters in pediatrics population age group 2 to 10 years |
| 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 Rama chatterjee |
| Designation |
Senior professor |
| Affiliation |
Senior professor department of anaesthesia |
| Address |
Department of anaesthesia 2nd floor dhanwantari block sms medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828622026 |
| Fax |
|
| Email |
chatterjeerama30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama chatterjee |
| Designation |
Senior professor |
| Affiliation |
Senior professor department of anaesthesia |
| Address |
Department of anaesthesia 2nd floor dhanwantari block sms medical College Jaipur
RAJASTHAN
302004
India |
| Phone |
9828622026 |
| Fax |
|
| Email |
chatterjeerama30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshan lal Meena |
| Designation |
Junior Resident |
| Affiliation |
Sms medical College jaipur |
| Address |
Vill dattwas the newai dis tonk Rajasthan
Tonk
RAJASTHAN
304025
India |
| Phone |
9549233630 |
| Fax |
|
| Email |
roshanmeena7994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sms medical College jaipur rajastah 302004 India |
|
|
Primary Sponsor
|
| Name |
Sms medical College Jaipur Rajasthan india |
| Address |
JLN Marg adarsh nagar jaipur rajastah 302004 india |
| 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 Roshan lal meena |
Sms medical College Jaipur |
JLN marg
Tonk Road
JK Loan Hospital
Sms medical College
Jaipur
Jaipur
RAJASTHAN |
9549233630
roshanmeena7994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee sms medical College and attached hospitals jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Elective Surgery under General Anaesthesia
Patient of Either Sex
ASAgrade 1-2
Age between 2-10 years
Parents willing to give consent for study. |
|
| ExclusionCriteria |
| Details |
Child with cranio facial deformity and cervical spine diseases
Any child had any neck and head tumor or head neck anomaly
Tracheobronchial malformations |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and determine the best assessment parameters MMT upper lip bit test for prediction of difficult intubation in pediatrics population age group 2 to 10 years |
Just before intubation with in 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensitivity of anthropometric measurement of thyromental , hyomenral, sternomental distance |
10 minutes
15 minutes
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
13/11/2024 |
| 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
|
Purpose of this study to investigate the effectiveness of the modified mallampati test; the upper lip bite test and anthropometric measurement of the head and neck(Thyromental, hynomental and sternomental distances) in the prediction of difficult airway in the pediatric population and their comparision with cormacklehane classification.
|