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

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ClinicalTrials.gov Identifier: NCT02083172
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Karen Choong, McMaster University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Hemodynamically Stable Critical Illness Device: Ultrasound Cardiac Output Monitor and 2 D-Echo

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 Design
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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating Agreement Between USCOM and 2D-echocardiographic Hemodynamic Measurements in Pediatric Patients
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016
Groups and Cohorts
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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 Name: 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 Name: 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 Name: USCOM


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083172


Locations
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Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Investigators
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Study Chair: Karen Choong, MD,BCh,MSc McMaster University
More Information
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Publications:
Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6. Erratum in: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].
Wongsirimetheekul T, Khositseth A, Lerbunrian R. (2013). Noninvasive cardiac output assessment in critically ill pediatric patients [poster]. Am J Respir Crit Care Med 187: A3686.
Lichtenthal PR, Sloniger JA, Copeland JG. (2007) USCOM non-invasive Doppler cardiac output: Are measurements accurate in infants and children? Anesthesiology 107: A1528.
Eguchi JH,Mathur M,Larsen R,et al.Ultrasound cardiac output monitor measurement in pediatric cardiac transplant patients.J Heart Lung Transplant,2007,26 (2):S136.
Lichtenthal PR, Phillips RA, Sloniger JA, et al. (2006) USCOM non-invasive Doppler: Are cardiac output measurements accurate in both infants and adults? Anesthesiology 105: A466
Phillips RA, Paradisis M, Evans NJ, et al. (2006) Validation of USCOM CO measurements in preterm neonates by comparison with echocardiography. Crit Care Med 10(S1): 144-343

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Responsible Party: Karen Choong, Associate professor, Departments of Pediatrics and Critical Care, McMaster University
ClinicalTrials.gov Identifier: NCT02083172    
Other Study ID Numbers: 13-658
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: November 2015
Keywords provided by Karen Choong, McMaster University:
USCOM (UltraSound Cardiac Output Monitor)
2D echocardiography
agreement
pediatrics
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes