CompletedNot Applicable

Comparing USCOM and Echocardiographic Hemodynamic Measurements in Children (CUE Study)

Canada78 participantsStarted 2014-07

Plain-language summary

The primary objective of this study is to evaluate the agreement between hemodynamic measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.

Who can participate

Age range1 Month – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age under 18 years * Patient fulfills clinical criteria for either study cohort * Most Responsible Physician has ordered an ECHO study on the patient * Written informed consent by parents/legal guardian/substitute decision maker, and assent where appropriate * Patients with normal cardiac structure, no pre-existing primary cardiovascular disease or hemodynamically insignificant shunt lesions (i.e. hemodynamically insignificant Atrial Septal Defect/Patent Foramen Oval and Ventricular Septal Defect Exclusion Criteria: * Age ≥ 18 years * Premature infants (born \<37 weeks gestation) admitted to the Neonatal Intensive Care Unit * Known co-existing primary cardiac anomalies (i.e. aortic or pulmonary valve stenosis or regurgitation, Aortic Valve regurgitation, shunt lesions save for those mentioned above, and pericardial effusion) * Prior enrollment in study

What they're measuring

Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo respectively, in hemodynamically stable children

Timeframe: Within 30 minutes of first measurement method

Trial details

NCT IDNCT02083172

SponsorMcMaster University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Hemodynamically Stable trials