Role of USCOM in Adult Patients With Heart Failure

Summary

Objective:

The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:

1. To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome (adHFS)
2. To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and DO2 correlate with heart failure staging, especially New York Heart Association (NYHA) class and American Heart Association (AHA) stage.
3. To investigate whether USCOM-derived haemodynamic parameters such as velocity time interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2 correlate with ejection fraction.
4. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).
5. To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of haemodynamically stable and unstable adult patients.

Design:

This prospective observational cohort study will be conducted in the Prince of Wales Hospital in Hong Kong.

Setting and Subjects:

Patients will be screened and recruited from adult patients either scheduled for elective 2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency department at the Prince of Wales Hospital.

Interventions:

Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to assess inter-observer variability, a second, blinded operator will repeated 15% of scans.

Conditions

• Acute Decompensated Heart Failure
• Congestive Heart Failure Compensated

Interventions

DEVICE

Ultrasonic cardiac output monitor

An Ultrasonic Cardiac Output Monitor, a non-invasive Doppler ultrasonography, is capable of measuring haemodynamic parameters non-invasively and appears to be simple and rapid to use, portable, relatively inexpensive and has less potential complications compared with the standard technique, pulmonary artery thermodilution (PATD). It has been compared favorably with a wide range of standard techniques, including PATD, with good interobserver reliability. USCOM may help on monitoring HF and suggesting proper treatment in order to reduce the mortality of adHF.

DEVICE

Echocardiography

2D-echo is a conventional standard-of-care tool for non-invasive hemodynamic assessments in adults. The use of 2D-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. It is used to find out the ejection fraction and to compare the haemodynamic parameters with USCOM in this study.

Sponsors & Collaborators

• Cardiff and Vale University Health Board

  collaborator OTHER_GOV

• University Hospitals, Leicester

  collaborator OTHER

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Timothy H Rainer, MD FCEM · Accident & Emergency Medicine Academic Unit

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2018-02-06

Completion

2018-02-06

Countries

• China

Study Locations