| CTRI Number |
CTRI/2018/04/012969 [Registered on: 03/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
To study predictors of difficult airway in children |
|
Scientific Title of Study
|
To determine the predictors of difficult airway in Paediatric age group:an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha mudgal |
| Designation |
Senior resident |
| Affiliation |
Safdarjung hospital |
| Address |
Department of anesthesia
Vmmc and safdarjung hospital
New Delhi
DELHI
110029
India |
| Phone |
9013356195 |
| Fax |
|
| Email |
pratibhamudgal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr mridula pawar |
| Designation |
Professor |
| Affiliation |
Safdarjung hospital |
| Address |
Department of anesthesia
Vmmc and safdarjung hospital
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
mridulapawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratibha mudgal |
| Designation |
Senior resident |
| Affiliation |
Safdarjung hospital |
| Address |
Department of anesthesia
Vmmc and safdarjung hospital
New Delhi
DELHI
110029
India |
| Phone |
9013356195 |
| Fax |
|
| Email |
pratibhamudgal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pratibha mudgal
Department of anesthesia
Vmmc and safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Pratibha mudgal |
| Address |
B-179 Mohan garden uttam Nagar new delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Pratibha mudgal |
Safdarjung hospital |
Operation theater 3rd floor
Vmmc and safdarjung hospital
New Delhi
DELHI |
9013356195
pratibhamudgal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 and 2, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Patients undergoing surgery under general anesthesia
children upto 6 years of age |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4
Children above 6 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predictors of difficult airway |
13 may 2014 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of predictors with difficult airway in different age ranges |
Correlation of predictors with difficult airway in different age ranges |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
in our study we assessed 500 Paediatric patients preoperatively on the basis of history, examination and measurements to identify predictors of difficult airway. In our study we found that in children less than 2 years of age parameters of airway assessment correlated better with the weight than the age of the infant and in the children above the age of 2 years mallampati class and Cormack Lehane grade was a better indicator of difficult airway.
|