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

March 14, 2016 updated by: Karen Choong, McMaster University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodynamically stable patients
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
Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.
Other Names:
  • USCOM
Hemodynamically unstable patients
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
Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.
Other Names:
  • USCOM
Mechanically ventilated patients
Patients requiring mechanical ventilation
Device: Ultrasound Cardiac Output Monitor and 2 D-Echo
Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.
Other Names:
  • USCOM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
Within 30 minutes of first measurement method

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Study Chair: Karen Choong, MD,BCh,MSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

March 7, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-658

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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