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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02289885
Other study ID # FAST/2014/02
Secondary ID
Status Recruiting
Phase N/A
First received November 7, 2014
Last updated November 10, 2014
Start date November 2014
Est. completion date December 2014

Study information

Verified date November 2014
Source International Institute of Rescue Research and Education
Contact Lukasz Szarpak
Phone +48500186225
Email lukasz.szarpak@gmail.com
Is FDA regulated No
Health authority Poland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial Summary

The study evaluates the knowledge, attitude and practice about Focused Assessment with Sonography in Trauma among emergency medicine practitioners in Poland.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Paramedics currently practicing in a Polish emergency department units and emergency medical services

- Age = 18 years

Exclusion Criteria:

- Inability to participate in all aspects of the study prior to study begin

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
SonoScape
Ultrasonography device

Locations

Country Name City State
Poland International Institute of Rescue Research and Education Warsaw

Sponsors (1)

Lead Sponsor Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tests of Knowledge of the FAST Examination knowledge-based measures used to evaluate participants' knowledge of FAST-examination-related concepts (Survey) 1 day No
Secondary FAST Performance Test The performance test required participants to conduct a FAST examination on two model patients (one normal, one ascites positive). No help or feedback was given to the participants. 1 day No
Secondary Window acquisition time Identification of FAST Window Quadrants and Diagnostic Interpretation of FAST Windows.
The window acquisition time was measured with a stopwatch and represented the period between first contact of the probe with the model patient's body and when the participant said "stop" to indicate an adequate window or the participant's judgment that he or she could not acquire the window.
1 day No
Secondary Window quality For each acquired window, an expert evaluated the quality of the window. The window was rated as "excellent, fair, poor, or other." "Other" captured situations where the window acquired was nondiagnostic. Window quality was dichotomized into two categories, "excellent or not excellent," and subsequent analyses examined the number of participants that acquired "excellent" windows by quadrant (perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis and suprapubic quadrant) and patient type (normal, positive). 1 day No
Secondary Diagnostic accuracy For each acquired window, the participant rendered a diagnosis of that window. An expert evaluated the quality of the diagnosis. The diagnosis was rated as "correct, incorrect, or other." "Other" captured situations where the window acquired was nondiagnostic. For analysis purposes, diagnostic accuracy was dichotomized into two categories, "correct or not correct," and subsequent analyses examined the number of participants that interpreted the window correctly by quadrant (perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis and suprapubic quadrant) and patient type (normal, positive). 1 day No
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