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

Study Overview
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Brief Summary
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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.

Detailed Description
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2D-echo is the standard-of-care tool for non-invasive hemodynamic assessments in children. The use of 2D-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. The feasibility of real time hemodynamic assessments is therefore limited with 2D-echo. USCOM has been introduced as a non-invasive bedside hemodynamic monitoring tool that utilizes continuous-wave Doppler ultrasound. As USCOM is easily portable, and measurements take only several minutes and can be conducted by trained physicians or nurses, it has become an attractive method of real time hemodynamic monitoring of unstable patients. While USCOM validation studies have been conducted in adult, neonatal and pediatric populations, the following concerns have been raised: a) Pediatric data on the agreement between USCOM and other standard methods of CO measurement (i.e. 2D-echo, pulmonary artery catheterization) are conflicting with some studies reporting acceptable agreement, while others report poor agreement ; b) USCOM validation and agreement studies were previously conducted in primarily hemodynamically stable populations. Its performance in hemodynamically unstable and mechanically ventilated patients has not been studied to date in the pediatric population.USCOM is currently being promoted as a real-time tool for assessing hemodynamic status, and directing the care of unstable children without adequate evidence. Therefore, this study is essential to inform the validity of USCOM and whether it can or should be used when 2D-echo for real time hemodynamic monitoring in children is not feasible or available.

Official Title
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Evaluating Agreement Between USCOM and 2D-echocardiographic Hemodynamic Measurements in Pediatric Patients

Conditions
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Hemodynamically Stable, Critical Illness

Intervention / Treatment
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* Device: Ultrasound Cardiac Output Monitor and 2 D-Echo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodynamically stable patients<br>Hemodynamically stable patients will be defined as patients with normal hemodynamic profile as evidenced by normal age-determined vital signs and normal perfusion. | Device: Ultrasound Cardiac Output Monitor and 2 D-Echo<br>* Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.<br>* Other names: USCOM;|
| Hemodynamically unstable patients<br>Hemodynamically unstable patients will be defined as patients who are admitted to the Pediatric Critical Care Unit (PCCU), in whom there is a clinical diagnosis of shock as evidenced by signs and symptoms of hypoperfusion, requiring fluid resuscitation and/or inotropic support. | Device: Ultrasound Cardiac Output Monitor and 2 D-Echo<br>* Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.<br>* Other names: USCOM;|
| Mechanically ventilated patients<br>Patients requiring mechanical ventilation | Device: Ultrasound Cardiac Output Monitor and 2 D-Echo<br>* Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.<br>* Other names: USCOM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo respectively, in hemodynamically stable children | Hemodynamic measurements are include cardiac output (CO), Stroke Volume (SV),Aortic cross sectional area (Ao CSA), Preload (SVV%) Inferior Vena cava Collapsibility index (IVC), Inotropy (SMI) and (EF) | Within 30 minutes of first measurement method | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo, in hemodynamically unstable children, and children receiving positive pressure ventilation respectively | Hemodynamic measurements are include Cardiac Output (CO), Stroke Volume(SV), Preload (SVV%) and IVC collapsibility Index, Inotropy | Within 30 minutes of first measurement method | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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USCOM (UltraSound Cardiac Output Monitor), 2D echocardiography, agreement, pediatrics