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Clinical Trials/CTRI/2025/04/084307
CTRI/2025/04/084307
Not yet recruiting
Not Applicable

"Comparison of Ultrasound Versus Conventional Formula-Based Assessment of Endotracheal Tube Size in Paediatric Patients Undergoing Surgery Under General Anesthesia: A Prospective Randomized Study"

Dr Sania Rodrigues1 site in 1 country60 target enrollmentStarted: April 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Sania Rodrigues
Enrollment
60
Locations
1
Primary Endpoint
to determine the appropriateness of the ETT size assessed by ultrasonography as compared to that assessed by the age based Coles formula .

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Ages
1.00 Year(s) to 6.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

to determine the appropriateness of the ETT size assessed by ultrasonography as compared to that assessed by the age based Coles formula .

Time Frame: Baseline

Secondary Outcomes

  • To determine whether the other methods to determine(the ETT size ,namely-height based, age based, & little finger diameter based)

Investigators

Sponsor
Dr Sania Rodrigues
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Sania Rodrigues

Dr. D.Y.Patil Medical College, Hospital and Research Centre

Study Sites (1)

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