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Ultrasound and Paediatric Endotracheal Tube Size

This study has been completed.
Sponsor:
Collaborator:
SonoSite, Inc.
Information provided by (Responsible Party):
Christoph Schramm, M.D., University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01535300
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

The aim of the present study was to evaluate the role of ultrasound in paediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different age-related formulas.

The investigators hypothesize that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTTD.


Condition Intervention
Uncuffed Endotracheal Intubation
 Procedure: Ultrasonography of the trachea

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Role of Ultrasound Compared to Age-related Formulas for Uncuffed Endotracheal Intubation in a Paediatric Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Enrollment: 50
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elective pediatric surgery Procedure: Ultrasonography of the trachea
Ultrasonographic measurement of the minimal transverse tracheal diameter

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children <= 5 years of age scheduled for elective surgery

Criteria

Inclusion Criteria:

  • written informed consent
  • children <= 5 years of age
  • elective surgery requiring endotracheal intubation

Exclusion Criteria:

  • missing informed consent
  • allergy to ultrasound gel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535300

Locations
Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University of Heidelberg
SonoSite, Inc.
Investigators
Study Chair: Konstanze Plaschke, Professor University of Heidelberg
Principal Investigator: Christoph Schramm, MD University of Heidelberg
  More Information

No publications provided

Responsible Party: Christoph Schramm, M.D., Principal Investigator, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01535300     History of Changes
Other Study ID Numbers: S234/2010
Study First Received: February 10, 2012
Last Updated: February 14, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
Ultrasound
Minimal transverse tracheal diameter
Endotracheal tube size
Paediatric age-based formulas
Sonographic measurement of the trachea

ClinicalTrials.gov processed this record on May 23, 2013