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Completed

NCT Number: NCT02083172

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

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound Cardiac Output Monitor and 2 D-Echo

Device

Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.

Other names: USCOM

Primary outcomes

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

    Time frame: Within 30 minutes of first measurement method

    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)

Secondary outcomes

  1. Agreement in hemodynamic measurements obtained by USCOM and 2D-Echo, in hemodynamically unstable children, and children receiving positive pressure ventilation respectively

    Time frame: Within 30 minutes of first measurement method

    Hemodynamic measurements are include Cardiac Output (CO), Stroke Volume(SV), Preload (SVV%) and IVC collapsibility Index, Inotropy

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 11, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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