| CTRI Number |
CTRI/2025/12/099890 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of ultrasound in selecting appropriate endotracheal tube size in children undergoing surgery |
|
Scientific Title of Study
|
Comparison of ultrasonographic measurement of glottic diameters with traditional formulas in prediction of appropriate endotracheal tube size in pediatric population – a prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PSG/IHEC/2025/Appr/Exp/422 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shenbaga Harini |
| Designation |
Post graduate |
| Affiliation |
PSG IMSR |
| Address |
Department of anaesthesiology,
PSG IMSR
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8870099688 |
| Fax |
|
| Email |
ssharini23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Silvy Anna Varughese |
| Designation |
Professor |
| Affiliation |
PSG IMSR |
| Address |
Department of anaesthesiology,
PSG IMSR,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9911514952 |
| Fax |
|
| Email |
drsilvyann@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Inamanamelluri Rachana |
| Designation |
Assistant professor |
| Affiliation |
PSG IMSR |
| Address |
Department of anaesthesiology,
PSG IMSR,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9397971978 |
| Fax |
|
| Email |
rachanainamanamelluri98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shenbaga Harini |
| Address |
Post graduate,
Department of anaesthesiology,
PSG IMSR,
COIMBATORE-641004 |
| 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 |
| Shenbaga Harini |
PSG Institute of Medical Sciences and Research |
Operation theatre -A, B, C block,
Department of Anaesthesiology, Operation Theatre,
Coimbatore, Tamil Nadu, India
Coimbatore
TAMIL NADU |
8870099688
ssharini23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)American Society of Anesthesiologists (ASA) physical status I or II.
2)Parental informed consent has obtained.
3)Children scheduled for elective surgical procedures requiring general anesthesia with endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1)Congenital airway anomalies
2)History of difficult intubation
3)Emergency surgery
4) Children with upper respiratory tract infections within the last 2 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the subglottic diameter and assess its co-relation with traditional methods in predicting appropriate endotracheal tube size in pediatric population |
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To measure the transverse glottic, midglottic diameter and assess its correlation between subglottic diameter
|
Intraoperative |
• To identify the incidence of Endotracheal tube changes required following initial intubation
|
Intraoperative |
| • To assess the incidence of complications [post operative stridor, improper ventilation, trauma ] when associated with initial inappropriate Endotracheal tube placement |
Immediate postoperative period |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
06/01/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective observational study aims to evaluate the accuracy of ultrasound-guided airway measurements in predicting the appropriate size of endotracheal tube in pediatric patients aged 1 to 12 years undergoing elective surgery under general anesthesia. Ultrasound measurements of subglottic diameter, transverse glottic diameter and mid-glottic diameter will be compared with traditional age-based, height-based and little finger formulas. The ultrasound findings will be correlated with the clinically appropriate endotracheal tube size determined intraoperatively. The study also evaluates the incidence of endotracheal tube changes and airway-related complications. By comparing the results of each method to the tube size that actually fits best, we aim to discover which one is truly the most precise. |