| CTRI Number |
CTRI/2021/03/032082 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
14/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prediction of tracheal tube size in children using ultrasound |
|
Scientific Title of Study
|
Comparison of ultrasound guided sub glottic diameter measurement versus traditional formulae in prediction of endotracheal tube size in pediatric population: Randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeeta chowdhury |
| Designation |
Senior Resident |
| Affiliation |
Central Hospital, South Eastern Railway, Kolkata 43 |
| Address |
Department of Anesthesiology
Operation Theatre
2nd floor
Central Hospital
South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL
700043
India |
| Phone |
8770570327 |
| Fax |
|
| Email |
doctorsangeetacnmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suryabrata Chattopadhyay |
| Designation |
Senior D.M.O. |
| Affiliation |
Central Hospital, South Eastern Railway Hospital, Kolkata 43 |
| Address |
Department of Anesthesiology
2nd Floor OT
Central Hospital
South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL
700043
India |
| Phone |
8585080522 |
| Fax |
|
| Email |
drsurya24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suryabrata Chattopadhyay |
| Designation |
Senior D.M.O. |
| Affiliation |
Central Hospital, South Eastern Railway Hospital, Kolkata 43 |
| Address |
Department of Anesthesiology
2nd Floor OT
Central Hospital
South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL
700043
India |
| Phone |
8585080522 |
| Fax |
|
| Email |
drsurya24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Hospital
South Eastern Railway
11 Garden Reach Road
Kolkata-700043 |
|
|
Primary Sponsor
|
| Name |
Central Hospital South Eastern Railway |
| Address |
Department of Anesthesiology
2nd Floor OT
Central Hospital
South Eastern Railway
11 Garden Reach Road
Kolkata 700043 |
| 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 |
| Dr Sangeeta Chowdhury |
Central Hospital, South Eastern Railway |
Department of Anesthesiology
2nd Floor OT
Central Hospital
South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL |
8770570327
doctorsangeetacnmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Central Hospital South Eastern Railway |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q37||Cleft palate with cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided measurements of sub glottic diameter |
After patient is sedated, ultrasound machine will be used to measure the sub glottic diameter which will help to select endotracheal tube of nearest outer diameter |
| Comparator Agent |
Ultrasound guided sub glottic diameter measurement |
measuring the sub glottic diameter by ultrasound to predict the size of endotracheal tube to be used |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
posted for cleft lip or cleft palate repair otherwise healthy |
|
| ExclusionCriteria |
| Details |
Non consent of parents
babies less than ideal weight for age
babies with cardiac anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy of ultrasound guided sub glottic diameter measurement versus traditional formulae in predicting size of endotracheal tube |
At baseline, no follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of usefulness traditional formulae in predicting endotracheal tube size |
1 year |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
22/03/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - By communicating with primary investigator
- For how long will this data be available start date provided 21-03-2021 and end date provided 10-03-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is a prospective, comparative, randomised control trial which aims to compare the efficacy of using ultrasound guided measurement of subglottic diameter versus traditional formulae to predict the size of endotracheal tube in children aged between 6 months to 8 years undergoing cleft lip or cleft palate surgery in Central hospital, South Eastern Railway, 11 Garden Reach Road, Kolkata 700043. The study will also compare various formulae used to select endotracheal tube size in pediatric population. |