Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

June 4, 2017 updated by: Raviwon Atisook, Siriraj Hospital
The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.

Study Type

Interventional

Enrollment (Actual)

93

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

  • Thailand
    • Bangkoknoi
      • Bangkok, Bangkoknoi, Thailand, 10700
        • Raviwon Atisook

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

1 year to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 1-6 Years
  • ASA class 1-2
  • Elective Surgery
  • GA with oral uncuff endotracheal tube

Exclusion Criteria:

  • Potential difficult air way from history and physical exam
  • Allergy ti ultrasound gel
  • neck mass
  • unstable vital sign

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
Using ultrasound measurement of the subglottic area to choose endotracheal tube size
Diagnostic test: Ultrasound
Using ultrasound to determine the size of endotracheal tube
No Intervention: Formula
Using Cole's formula to choose endotracheal tube size

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proper size of endotracheal tube
Time Frame: 1 year
Clinically fit of endotracheal tube with leak at 20-25 cmH2O
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of subglottic diameter and proper size endotracheal tube
Time Frame: 1 year
Correlation of subglottic diameter measured by ultrasound and proper size endotracheal tube determined by clinically fit.
1 year

Collaborators and Investigators

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

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Raviwon Atisook, Department of anesthesiology siriraj hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 4, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RAti-001

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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