NCT02304133

Brief Summary

This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
Last Updated

December 1, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

November 24, 2014

Last Update Submit

November 25, 2014

Conditions

Ultrasonography

Outcome Measures

Primary Outcomes (2)

  • Ultrasound performance

    An Objective Structured Assessment of Ultrasound Skills (OSAUS) scoring form was used to assess ultrasound performance

    4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances

  • Diagnostic accuracy

    The ultrasound diagnoses were evaluated as "correct," "inconclusive," or "false," and the diagnostic accuracy was calculated by sensitivity and specificity

    4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances

Study Arms (2)

Intervention

ACTIVE COMPARATOR

participating in a four-hour course in abdominal POC US

Other: Education

Control

PLACEBO COMPARATOR

no training

Other: Education

Interventions

EducationOTHER
ControlIntervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical Doctor
  • Signed up for a courses in abdominal point-of-care ultrasound

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Todsen T, Jensen ML, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Ringsted C. Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial. Am J Surg. 2016 Jan;211(1):40-5. doi: 10.1016/j.amjsurg.2015.05.025. Epub 2015 Jul 31.

    PMID: 26323998DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 1, 2014

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

November 1, 2014

Last Updated

December 1, 2014

Record last verified: 2014-11