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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083172
• Other study ID #: 13-658
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: March 14, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Hemodynamically Stable

Intervention

Device:
• Ultrasound Cardiac Output Monitor and 2 D-Echo
Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No