Comparing USCOM and Echocardiographic Hemodynamic Measurements in Children (CUE Study) (NCT02083172) | Clinical Trial Compass
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 range
1 Month – 18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo respectively, in hemodynamically stable children
Timeframe: Within 30 minutes of first measurement method