| CTRI Number |
CTRI/2025/03/083123 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Diagnostic
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In Pediatric Age Group, Ultrasound based prediction of Best Fitting Endotracheal Tube Size, by correlating Transverse Cricoid Diameter and Transverse Epiphyseal Diameter of Distal End of Radius |
|
Scientific Title of Study
|
STANDARD ENDOTRACHEAL TUBE OUTER DIAMETER CO-RELATION BETWEEN TRANSVERSE CRICOID DIAMETER VS EPIPHYSEAL TRANSVERSE DIAMETER OF DISTAL END RADIUS: ULTRASOUND ASSISTED PREDICTION OF BEST FITTING PEDIATRIC ENDOTRACHEAL TUBE SIZE. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sriya Vaishnavi Tallapragada |
| Designation |
MD Anaesthesiology |
| Affiliation |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center |
| Address |
Department of Anaesthesiology
JNMC Belagavi
Karnataka, India
590010
Chandigarh
CHANDIGARH
160015
India |
| Phone |
8054262555 |
| Fax |
|
| Email |
svtallapragada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh S Mane |
| Designation |
Professor and Head, Anaesthesiology |
| Affiliation |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center |
| Address |
Department of Anaesthesiology
JNMC Belagavi
Karnataka, India
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriya Vaishnavi Tallapragada |
| Designation |
MD Anaesthesiology |
| Affiliation |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center |
| Address |
Department of Anaesthesiology
JNMC Belagavi
Karnataka, India
590010
CHANDIGARH
160015
India |
| Phone |
8054262555 |
| Fax |
|
| Email |
svtallapragada@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
JNMC Belagavi
Karnataka
590010 |
|
|
Primary Sponsor
|
| Name |
Dr Sriya Vaishnavi Tallapragada |
| Address |
Department of Anaesthesiology
JNMC, Belgaum
Karnataka
590010 |
| 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 |
| Dr Sriya V Tallapragada |
JNMC Belagavi |
Department of Anaesthesiology
Jawaharlal Nehru Medical College, KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Belgaum, Karnataka 590010
Belgaum
KARNATAKA |
918054262555
svtallapragada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Age based formula calculation of endotracheal tube size |
Traditional age-based formulas (e.g., ETT ID = (Age/4) + 4) serve as a general guide but often fail to accommodate anatomical variability due to factors like prematurity, growth abnormalities, or other physiological differences. . Predictive formulas based on patient weight and height have also been tested. |
| Intervention |
Ultrasound assisted prediction of best fitting pediatric endotracheal tube size |
Standard endotracheal tube outer diameter co-relation between transverse cricoid diameter vs epiphyseal transverse diameter of distal end radius scan via USG, measured under 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Age : 5-15 years
ASA - I ,II
Elective surgeries
Consent given
|
|
| ExclusionCriteria |
| Details |
Airway deformities (congenital)
Preoperative sore throat or URTI
Allergy to local anaesthetic
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to compare USG measured transverse cricoid diameter and radial epiphyseal diameter in predicting appropriate size endotracheal tube.
|
Baseline values |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective is number of attempts of intubation |
Baseline value |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/04/2025 |
| 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="0"
Months="6"
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
|
Reliability of predicting the proper endotracheal tube is imperative in pediatric anaesthesia practice to promote ease of induction and to avoid airway complications due to repeated intubation trials. Intubation with an endotracheal tube thet is too small may result in insufficient ventilation, poor reliability of end tidal gas monitoring leak of anaesthetic gases into the operating room environment, and enhanced risk of aspiration. In contrast, an endotracheal tube too large can cause upper airway damage and potential for subsequent subglottic stenosis. This study is to test the hypothesis of accuracy of ultrasound guided transverse cricoid diameter and epiphyseal transverse diameter of distal radius in predicting the paediatric endotracheal tube size. |