Ultrasound and Pediatric Endotracheal Tube Size | NCT01877980

Studies
Ultrasound and Pediatric Endotracheal Tube Size

NCT01877980

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

101Actual

Phase

Not provided

Conditions

Intubation With Uncuffed Endotracheal Tube

Interventions

Not provided

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

Dec 2014

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

Apr 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jun 5, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 14, 2013Estimated

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

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

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 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.

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

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

101Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Minimal transverse airway Diameter (MTAD)	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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed informed consent by the legal guadian
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

6 Years

Standard Ages

Child

Study Population

Children scheduled for elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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