| CTRI Number |
CTRI/2019/05/019014 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A find out if there is difficulty in putting the tube in the wind pipe in children before surgery. |
|
Scientific Title of Study
|
Ultrasound evaluation to predict difficult airway in children below 2 years: an observational trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhkarman Kahlon |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of anaesthesia
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417947708 |
| Fax |
|
| Email |
shubhiekahlon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Jain |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of anaesthesia
PGIMER
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
|
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Jain |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of anaesthesia
PGIMER
sector 12
Chandigarh
Department of anaesthesia
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160022
India |
| Phone |
7087008020 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of anaesthesia
PGIMER
Sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Divya Jain |
Postgraduate institute of medical education and Research |
Department of anaesthesia
PGIMER
Sector 12
Chandigarh
CHANDIGARH |
7087008020
jaindivya77@rediffmail.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 |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
undergoing surgery under general anaesthesia requiring endotracheal tube insertion |
|
| ExclusionCriteria |
| Details |
1. Children requiring placement of supraglottic airway.
2. Parents’ refused consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hyomental ratio |
10 minutes before induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tongue thickness/oral cavity thickness
Tongue thickness/thyromental ratio |
10 minutes before induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2019 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The ultrasound airway parameters in children less than 2 years would be used to predict difficulty in laryngoscopy or intubation. |