| CTRI Number |
CTRI/2019/05/019134 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study for identifying the parameters helping in prediction of Difficult Airway during Anaesthesia administration in children between 3-15 years of age. |
|
Scientific Title of Study
|
Study of the predictors of Difficult Airway in children aged 3-15 years posted for surgery under General Anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana Mohan |
| Designation |
Post Graduate First Year |
| Affiliation |
LADY HARDINE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS |
| Address |
Department Of Anaesthesia
LHMC and Associated hospitals,
C-604, Shaheed Bhagat Singh Road
DIZ area,Connaught place
New Delhi
Delhi 110001
Department Of Anaesthesia
LHMC and Associated hospitals,
C-604, Shaheed Bhagat Singh Road
DIZ area,Connaught place
New Delhi
Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9567669006 |
| Fax |
|
| Email |
sanjana.m015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anshu Gupta |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College and Associated Hospitals |
| Address |
Department Of Anaesthesia
LHMC and Associated Hospitals,
C-604 ,Shaheed Bhagat Singh road
DIZ area,Connaught place
New delhi
Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9711000264 |
| Fax |
|
| Email |
anug71@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjana Mohan |
| Designation |
Post Graduate First Year |
| Affiliation |
Lady Hardinge Medical College and Associated Hospitals |
| Address |
Department of Anaesthesia
LHMC and Associated Hospitals,
C-604 Shaheed Bhagat Singh Road,
DIZ area,Connaught place
New Delhi
Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9567669006 |
| Fax |
|
| Email |
sanjana.m015@gmail.com |
|
|
Source of Monetary or Material Support
|
| LHMC and Associated Hospitals
c-604 Shaheed Bhagat Singh Road
DIZ area,Connaught Place
New Delhi
Delhi 110001
|
|
|
Primary Sponsor
|
| Name |
LHMC and Associated hospitals |
| Address |
C-604,Shaheed Bhagat Singh Road
DIZ area,Connaught Place
New Delhi,Delhi PIN 110001 |
| 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 |
| Sanjana Mohan |
LHMC and associated hospitals |
C-604
Shaheed Bhagat Singh Road
DIZ area
Connaught Place
New delhi
PIN 110001
New Delhi
DELHI |
9567669006
sanjana.m015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LHMC and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All patients between 3-15 years posted for surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
children with midline neck mass, unstable cervical spine and who are uncooperative |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predictive value of pre operative airway parameters in difficult airway in children 3-15 years of age posted for surgery under general anaesthesia |
pre operative and before intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship of Thyromental and Sternomental distance with age , weight and height of children |
pre operatively |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
27/05/2019 |
| 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="9"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study will be conducted to assess pre operatively the parameters which helps in predicting difficult airway in children aged between 3-15 years and to study the relationship of thyromental and sternomental distance with age , weight and height of children.The primary outcome of the study will be the predictive value of pre operative airway parameters in difficult airway in children 3-15 years of age posted for surgery under general anaesthesia and relationship of thyromental and sternomental distance with age,weight and height of children. |