| CTRI Number |
CTRI/2026/01/102184 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of ultrasound to identify the correct size of tube for children undergoing surgery |
|
Scientific Title of Study
|
The comparision of ultrasound measured transverse cricoid diameter and the epiphyseal transverse diameter of the distal radius for predicting the paediatric endotracheal tube size : a prospective randomized study |
| 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 SNEHA S |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, NEURO OT COMPLEX, Indira Gandhi Institute of Medical Sciences
Patna
BIHAR
800014
India |
| Phone |
9481223397 |
| Fax |
|
| Email |
snehasrinivas007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SNEHA S |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, NEURO OT Complex, Indira Gandhi Institute of Medical Sciences
Patna
BIHAR
800014
India |
| Phone |
9481223397 |
| Fax |
|
| Email |
snehasrinivas007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Singh |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, NEURO OT COMPLEX, Indira Gandhi Institute of Medical Sciences
Patna
BIHAR
800014
India |
| Phone |
9481223397 |
| Fax |
|
| Email |
drswatisingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna 800014 |
|
|
Primary Sponsor
|
| Name |
DR SNEHA S |
| Address |
Department of Anaesthesiology, NEURO OT Complex, Indira Gandhi Institute of Medical Sciences |
| 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 SNEHA S |
Indira Gandhi Institute of Medical Sciences, Patna |
Department of Anaesthesiology, NEURO OT COMPLEX, Indira Gandhi Institute of Medical Sciences
Patna
BIHAR |
9481223397
snehasrinivas007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided transverse cricoid diameter |
After induction of anaesthesia and before intubation, the transverse cricoid diameter will be measured using ultrasound guidance in order to calculate the appropriate size endotracheal tube for endotracheal intubation in the patient. |
| Intervention |
Ultrasound guided transverse epiphyseal diameter of radius |
After induction of anaesthesia and before intubation, ultrasound probe will be used to measure the transverse epiphyseal diameter of radius in order to calculate the appropriate size endotracheal tube for intubation in the patient |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Paediatric patients of ASA physical status 1 and 2
2. Paediatric patients scheduled for surgery under general anaesthesia with endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1.Patients with airway malformations or previous surgery in the upper airway, recent respiratory infections, or illness, and those with an anticipated difficult airway
2.Patients requiring nasotracheal intubation
3.Patients with history of distal radius fracture |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The agreement between the reference tube size based on either the US-TCD or the US-EDR and the final BFT. |
IN OPERATION THEATRE (ZERO HOUR) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tube insertion score (Easy/ easy with leak/ Resistant) |
In operation theatre during endotracheal intubation |
| The number of insertion attempts |
In operation theatre during endotracheal intubation |
| Endotracheal tube exchanges if any will be recorded |
In operation theatre during endotracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="232"
Sample Size from India="232"
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 4 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The choice of endotracheal tube size in paediatric patients is mostly guided by various formulas that predict the inner diameter of the ET tube whether uncuffed or cuffed based on weight, age, height, and finger size. Airway ultrasound has recently been identified as an accurate alternative to these formulas. The ultrasound assessment of the transverse cricoid diameter haas been demonstrated to accurately predict the OD of the ETT that best fits the paediatric airway preventing unnecessary tube exchanges with resultant airway edema. The US measured epiphyseal diameter of the distal radius is a recently introduced method as a surrogate for the tracheal diameter. |