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

November 17, 2017 updated by: Ayse Cigdem Tutuncu, Istanbul University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cerrahpasa
      • Istanbul, Cerrahpasa, Turkey, 34098
        • Cerrahpasa Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intubation with Cole formula
ASA I-II pediatric patients in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation,
Procedure: Intubation
elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Actual)

October 25, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

August 20, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 83045809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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