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Ultrasound and Paediatric Endotracheal Tube Size

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ClinicalTrials.gov Identifier: NCT01535300
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : February 17, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Uncuffed Endotracheal Intubation Procedure: Ultrasonography of the trachea

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
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
Study Start Date : August 2010
Primary Completion Date : October 2010
Study Completion Date : October 2010

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Elective pediatric surgery Procedure: Ultrasonography of the trachea
Ultrasonographic measurement of the minimal transverse tracheal diameter


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535300


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

Responsible Party: Christoph Schramm, M.D., Principal Investigator, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01535300     History of Changes
Other Study ID Numbers: S234/2010
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

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