Comparing USCOM and Echocardiographic Hemodynamic Measurements in Children (CUE Study)
Condition: Hemodynamically Stable; Critical Illness
MeSH terms: Critical Illness
Study type: Observational

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.
    

Detailed description: 
      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.
    

Intervention name(s): Ultrasound Cardiac Output Monitor and 2 D-Echo
Intervention type(s): Device
Intervention description(s): Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.
Other intervention name(s): USCOM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. The hemodynamically stable group: will be screened from pediatric in-patients on
             McMaster Children's Hospital general pediatric wards and those scheduled for elective
             2D-echo through cardiology and sedation clinic.

          2. The hemodynamically unstable patients and 3. those requiring mechanical ventilation
             will be screened from McMaster Children's Hospital Pediatric Critical Care Unit.
      
Keywords: USCOM (UltraSound Cardiac Output Monitor); 2D echocardiography; agreement; pediatrics