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Timing For Single View Bedside Cardiac Ultrasound (REASON-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927755
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Romolo Gaspari, University of Massachusetts, Worcester

Brief Summary:
The goal of this study is to measure the hypothetical minimal amount of time it takes to perform a single view bedside trans-thoracic echo (TTE) comparing sub-xyphoid view and the parasternal long view. Physicians will be timed from initiation of imaging to completion of the recording of a single view of the heart. Images will be rated for quality.

Condition or disease Intervention/treatment
Echocardiography Other: Education

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Study Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REASON 2 Trial - Timing For Single View Bedside Cardiac Ultrasound
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Sub-xyphoid
Ultrasound views of the heart obtained using the sub-typhoid approach. Individuals with a mix of co-morbidities but are clinically stable will be viewed. Physicians with experience in bedside ultrasound are being studied.
Other: Education
Physicians will undergo training on how to rapidly obtain appropriate images.

Para-sternal Long
Ultrasound views of the heart obtained using the parasternal long approach. Individuals with a mix of co-morbidities but are clinically stable will be viewed. Physicians with experience in bedside ultrasound are being studied.
Other: Education
Physicians will undergo training on how to rapidly obtain appropriate images.




Primary Outcome Measures :
  1. Timing of Ultrasound Imaging [ Time Frame: 10 seconds ]
    Number of seconds from start to finish of the ultrasound imaging


Secondary Outcome Measures :
  1. Quality of Ultrasound Imaging [ Time Frame: 5 seconds ]
    The quality of the ultrasound images based on an ordinal numeric scale of image quality. Minimum =1 and maximum =5. Higher numbers equal better imaging quality. There is no subscale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All physicians participating in existing ultrasound educational programs will be considered for enrollment.
Criteria

Inclusion Criteria:

  • Physicians with experience in bedside cardiac ultrasound

Exclusion Criteria:

  • Unwilling to consent to study
  • Appropriate ultrasound equipment not available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927755


Locations
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United States, Massachusetts
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Romolo Gaspari, MD. PhD UMASS Medical School
Publications:

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Responsible Party: Romolo Gaspari, Professor, Department of Emergency Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03927755    
Other Study ID Numbers: UMASS-ED-4-22-19
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be presented at scientific meetings and published in peer reviewed publications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: available after completion of statistical review and write up of results.
Access Criteria: Freely available to whomever requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romolo Gaspari, University of Massachusetts, Worcester:
Bedside Ultrasound