Trial Outcomes & Findings for Focused Cardiac Ultrasound (NCT NCT03887286)

Results Overview

Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Day 1

Results posted on

2020-06-16

Participant milestones
Measure	Treatment Group All participants to receive standard transthoracic echocardiogram and hand held echocardiogram Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Treatment Group n=47 Participants All participants to receive standard transthoracic echocardiogram and hand held echocardiogram Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device
Age, Continuous	7.8 years STANDARD_DEVIATION 8.6 • n=47 Participants
Sex: Female, Male Female	19 Participants n=47 Participants
Sex: Female, Male Male	28 Participants n=47 Participants
weight	27.24 kg STANDARD_DEVIATION 23.41 • n=47 Participants

Timeframe: Day 1

Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography

Outcome measures
Measure	Standard Transthoracic Echocardiogram Intervention n=47 Participants The transthoracic echocardiogram was performed and read via Intersocietal Commission Accreditation Echocardiography Laboratories (ICAEL) standard	Hand Held Echocardiography n=47 Participants The hand held echocardiogram was performed and read via Intersocietal Commission Accreditation Echocardiography Laboratories (ICAEL) standard
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. minor cardiac abnormality	9 Participants	4 Participants
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. normal anatomy	13 Participants	13 Participants
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. major cardiac abnormality	25 Participants	23 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Miami

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