Ultrasound and Pediatric Endotracheal Tube Size (SoTu2)

December 2, 2014 updated by: Christoph Schramm, M.D., Heidelberg University

Prediction of Uncuffed Endotracheal Tube Size in a Pediatric Population by Sonographic Measurements at Various Structures of the Airway Compared to Age-related Formulas and Little-finger Diameters

The aim of the present study was to evaluate the ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger.

Previous studies already showed that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTAD. In this study measurements are performed at three predefined anatomic structures of the airway with each of These at two airway pressures.

The investigators hypothesize that one of the specific measurements predicts the fitting ETT size better than age-related formulas or diameter of little finger.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

101

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

    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • University of Heidelberg

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

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children scheduled for elective surgery

Description

Inclusion Criteria:

  • signed informed consent by the legal guadian
  • elective surgery requiring endotracheal intubation

Exclusion Criteria:

  • missing informed consent
  • allergy to ultrasound gel

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal transverse airway Diameter (MTAD)
Time Frame: Between administration of muscle relaxant and intubation (3min)
In this study measurements of MTAD are performed at three predefined anatomic structures of the airway with each of these at two airway pressures in the time frame between the administration of muscle relaxant and Intubation (average time available 3min).
Between administration of muscle relaxant and intubation (3min)

Collaborators and Investigators

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

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

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • S021/2013

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.

Clinical Trials on Intubation With Uncuffed Endotracheal Tube

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