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Completed

NCT Number: NCT03280498

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

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.

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Key information

Conditions

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cerrahpasa Medical Faculty

Istanbul, Cerrahpasa, 34098, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Intubation

Procedure

elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted

Primary outcomes

  1. : 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.

    Time frame: 12 months

    efficiency of formula

Secondary outcomes

  1. 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

    Time frame: 12 months

    efficiency of USG

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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