| CTRI Number |
CTRI/2018/06/014673 [Registered on: 29/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to use physical measurements to predict difficulty in laryngoscopy during anaesthesia induction in children undergoing surgery. |
|
Scientific Title of Study
|
Evaluation of Airway parameters to predict difficult Laryngoscopy in paediatric patients undergoing surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautham Srinivasan |
| Designation |
Post Graduate |
| Affiliation |
VMMC and Safdarjung Hospitals |
| Address |
Post Graduate In Dept Of Anaesthesia and Critical care
VMMC and Safdarjung Hospitals
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9486058101 |
| Fax |
|
| Email |
gauthamsvasan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pramod Gupta |
| Designation |
professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospitals |
| Address |
Dept Of Anaesthesia and Critical care
VMMC and Safdarjung Hospitals
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8130896905 |
| Fax |
|
| Email |
guptapdnb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Gautham Srinivasan |
| Designation |
Post Graduate |
| Affiliation |
VMMC and Safdarjung Hospitals |
| Address |
Post Graduate In Dept Of Anaesthesia and Critical care
VMMC and Safdarjung Hospitals
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9486058101 |
| Fax |
|
| Email |
gauthamsvasan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Critical care. Vardhaman Mahavir Medical College and Safdarjung hospital.New Delhi. |
|
|
Primary Sponsor
|
| Name |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Dept of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospitals
New Delhi 110029 |
| 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 |
| Gautham Srinivasan |
VMMC and Safdarjang Hospitals |
Dept of Anaesthesia and Intensive Care. Main OT complex.Third floor. Paediatric OTs
VMMC and Safdarjung Hospital
New Delhi 110029
New Delhi
DELHI |
9486058101
gauthamsvasan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Paediatric Patients (6 tp 12 years) undergoing surgery under General anaesthesia requiring intubation., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of either gender posted for elective surgery requiring endotracheal intubation.
American Society of Anaesthesiologists grade I and II. |
|
| ExclusionCriteria |
| Details |
Children with upper respiratory tract infection or reactive airway disease.
BMI> 35
Children with swelling / mass in the neck, limited neck extension, craniofacial abnormalities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing each airway parameter with Cormack Lehane grading for assessing difficult laryngoscopy in children undergoing surgery. |
Day of laryngoscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensitivity and Specificity of all airway parameters.
Negative and positive predictive value of all airway parameters. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/05/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Difficulty in airway management in paediatric patients is a major reason for cardiac arrest , brain injury and death. Predicting difficulties that would arise during airway management is of prime importance. This study aims to compare different airway parameters like Thyromental distance to height ratio, interinscisor distance to weight ratio, tragus to nares distance, sternomental distance, nose to chin distance, mallampati grading , upper lip bite test and head circumference in predicting difficult laryngoscopy in paediatric patients. Sensitivity, specificty, negative predictive value and positive predictive value for all parameters will be calculated. Receiver Operating Curves will be used to find out area under curve of various parametrs for predicting difficult laryngoscopy. All parameters are compared with Cormack Lehane grading during laryngoscopy. Grades III and IV will be considered difficult laryngoscopy. |