Ultrasound and Paediatric Endotracheal Tube Size | NCT01535300

Studies
Ultrasound and Paediatric Endotracheal Tube Size

NCT01535300

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Feb 17, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Uncuffed Endotracheal Intubation

Interventions

Ultrasonography of the trachea

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Feb 10, 2012

First Submission Date that Met QC Criteria

Feb 14, 2012

First Posted Date

Feb 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2012

Last Update Posted Date

Feb 17, 2012Estimated

Name	Class
SonoSite, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elective pediatric surgery			Procedure: Ultrasonography of the trachea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography of the trachea	Procedure	Ultrasonographic measurement of the minimal transverse tracheal diameter	Elective pediatric surgery

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

Children <= 5 years of age scheduled for elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstanze Plaschke, Professor	Heidelberg University	Study Chair
Christoph Schramm, MD	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg		Heidelberg		69120	Germany