| CTRI Number |
CTRI/2025/04/084307 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
"Comparing Ultrasound and Traditional Methods to Select the Right Breathing Tube Size for Children During Surgery" |
|
Scientific Title of Study
|
"Comparison of Ultrasound Versus Conventional Formula-Based Assessment of Endotracheal Tube Size in Paediatric Patients Undergoing Surgery Under General Anesthesia: 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 |
Sania Rodrigues |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8547770421 |
| Fax |
|
| Email |
judith27sania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipul K Sharma |
| Designation |
Professor,Dept Of Cardiac Anaesthesia |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Cardiac Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7251888789 |
| Fax |
|
| Email |
vipulsharmacta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipul K Sharma |
| Designation |
Professor,Dept Of Cardiac Anaesthesia |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Cardiac Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7251888789 |
| Fax |
|
| Email |
vipulsharmacta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Sania Rodrigues |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune-411018 |
| 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 Sania Rodrigues |
Dr. D.Y. Patil Hospital and Research Centre |
Department of
Anaesthesia, 5th Floor,
Hi-tech building, Dr.
D.Y.Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune 411018
Pune
MAHARASHTRA |
8547770421
judith27sania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
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 |
compare ultrasound versus conventional formula based assessment of endotracheal tube size in pediatric patients undergoing surgery under general anesthesia. |
In this study, pediatric patients undergoing surgery under general anesthesia were randomized into two groups for assessment of optimal endotracheal tube (ETT) size. In the ultrasound group (intervention), airway ultrasonography was used to measure the transverse subglottic diameter at the level of the cricoid cartilage using a high-frequency linear probe. The ETT size was selected based on the measured diameter, with all scans performed preoperatively by a trained anesthesiologist. In the conventional formula group (comparator), the ETT size was determined using Cole’s age-based formula: ETT size (mm) = (Age/4) + 4, rounded to the nearest commercially available tube size. Additionally, for all patients, other commonly used methods to estimate ETT size—namely, height-based formula, age-based formula, and the diameter of the patient’s little finger—were recorded to evaluate their correlation with both ultrasonographic findings and Cole’s formula. The actual ETT size used was confirmed based on clinical assessment, including leak test and adequacy of ventilation. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
American Society of
Anesthesiologists Physical Status I and II
Inclusion criteria :
o Either sex
o Patients aged 1-6 years of ASA I or ASA II undergoing surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
Exclusion criteria :
o Parental or Guardian refusal
o Patient with recent history of upper respiratory infection,any anticipated difficult airway ,any
anatomical deformity of upper airway,previous surgery involving upper airway,any obvious
scars,mass or ulcer in the neck which may interfere with ultrasound examination.
o Age less than 1 year |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine the appropriateness of the ETT size assessed by ultrasonography as compared to that assessed by the age based Coles formula . |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine whether the other methods to determine
the ETT size ,namely-height based, age based, & little finger diameter based
correlate with the findings of Ultrasonography & Coles formula. |
The study evaluates at baseline the methods for determining paediatric ETT size. Preoperative measurements (height, age, little finger diameter) & Coles formula estimates will be compared with intra-operative ultrasound findings. Post-intubation, success rates, intubation time, & tube exchanges will be assessed. Postoperative monitoring includes complications like stridor, correlating results with ultrasound & Coles formula. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/04/2025 |
| 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="1"
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
|
This prospective randomized study aims to compare ultrasound-guided assessment with conventional formula-based methods for determining the appropriate endotracheal tube (ETT) size in pediatric patients undergoing surgery under general anesthesia. The primary objective is to evaluate the accuracy of ETT size selection using ultrasonography compared to the age-based Coles formula. Secondary objectives include assessing correlations between ETT size determined by other methods—height-based, age-based, and little finger diameter-based—with findings from ultrasonography and the Coles formula. Key outcomes include first-attempt success rates, intubation time, tube exchanges, and post-operative respiratory complications, providing evidence-based insights for pediatric anesthesia practice. |