NCT01877980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

June 5, 2013

Last Update Submit

December 2, 2014

Conditions

Intubation With Uncuffed Endotracheal Tube

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children scheduled for elective surgery

You may qualify if:

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

You may not qualify if:

  • missing informed consent
  • allergy to ultrasound gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 14, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

DE(1)