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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04521933
Other study ID # 09/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 28, 2020
Est. completion date January 31, 2021

Study information

Verified date February 2021
Source Emergency Medical Service of the Central Bohemian Region, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate reliability of subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.


Description:

Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability. Physicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date January 31, 2021
Est. primary completion date December 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire Exclusion Criteria: - not meet the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Each participant completes a questionnaire. In the questionnaire, he performs a subjective qualitative evaluation of Point-of-Care ultrasound records of the heart. Each participant will complete a questionnaire in which they perform a subjective qualitative evaluation of ultrasonographic recordings of the heart.

Locations

Country Name City State
Czechia Masaryk Hospital Usti nad Labem Usti nad Labem

Sponsors (2)

Lead Sponsor Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic Masaryk Hospital Usti nad Labem

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Review. Erratum in: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography Subjective assessment of Point-of-Care ultrasound records of the heart will be performed by participants via completion of the questionnaire. Thereafter, results of the survey will be compared with the objective measurements taken by conventional transthoracic echocardiography from the same records than presented in the questionnaire. four weeks
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