Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate Endotracheal Tube Size

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Procedure: Intubation

• Registration Number: NCT03280498
• Lead Sponsor: Istanbul University

Brief Summary

In this study the effectiveness of the use of Cole formula and USG were compared in determining the number of the appropriate uncuffed ETT to be used for clinically adequate ventilation.

Detailed Description

Aim: The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.

Material and methods: ASA I-II pediatric patients (n=110) in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation, were enrolled in this study. Once patients were properly positioned after premedication and anesthesia induction, the subglottic diameter was measured using ultrasonography, and endotracheal tube (ETT) size was also calculated with the Cole formula. Subsequently patients were entubated with uncuffed ETT with sizes based on the patient's age in compliance with current clinical guide lines. To ensure adequate ventilation, the tube was replaced with an ETT of larger or smaller diameter as needed. The ETT was fastened after the placement ring had passed through the vocal cords and breath sounds were confirmed to be equal by auscultation. The size of the used ETT was compared with the size estimated from the subglottic diameter measured by ultrasonography to the size calculated with the Cole formula

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-08-20
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Children between 2 and 10 years of age, in the ASA I-II classification for whom elective surgery

Exclusion Criteria

Children having a diagnosed syndrome, any anomaly of the upper respiratory tract and the head-neck region, recent or active upper respiratory tract infection, previous tracheastomy, requiring nasotracheal entubation, requiring surgery on an emergency basis and being in the ASA III-IV classification -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intubation with Cole formula	Intubation	ASA I-II pediatric patients in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation,

Primary Outcome Measures

Name	Time	Method
: The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.	12 months	efficiency of formula

Secondary Outcome Measures

Name	Time	Method
To determine the correlation of weight, height and age of child with USG based endotracheal tube size, Cole formula endotracheal tube size and clinically used endotracheal tube size	12 months	efficiency of USG

Trial Locations

Locations (1)

Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Cerrahpasa, Turkey