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

NCT02083172 | Completed

• 1 other identifier: 13-658
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamically Stable; Critical Illness

Keywords

USCOM (UltraSound Cardiac Output Monitor); 2D echocardiography; agreement; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Within 30 minutes of first measurement method

Study Arms (3)

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

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

Mechanically ventilated patients

Patients requiring mechanical ventilation

Device: Ultrasound Cardiac Output Monitor and 2 D-Echo

Interventions

Ultrasound Cardiac Output Monitor and 2 D-Echo DEVICE

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

Also known as: USCOM

Hemodynamically stable patients; Hemodynamically unstable patients; Mechanically ventilated patients

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (41)

• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

  PMID: 11445675 BACKGROUND

• Odetola FO, Gebremariam A, Freed GL. Patient and hospital correlates of clinical outcomes and resource utilization in severe pediatric sepsis. Pediatrics. 2007 Mar;119(3):487-94. doi: 10.1542/peds.2006-2353.

  PMID: 17332201 BACKGROUND

• Parrillo JE, Parker MM, Natanson C, Suffredini AF, Danner RL, Cunnion RE, Ognibene FP. Septic shock in humans. Advances in the understanding of pathogenesis, cardiovascular dysfunction, and therapy. Ann Intern Med. 1990 Aug 1;113(3):227-42. doi: 10.7326/0003-4819-113-3-227.

  PMID: 2197912 BACKGROUND

• Zanotti-Cavazzoni SL, Hollenberg SM. Cardiac dysfunction in severe sepsis and septic shock. Curr Opin Crit Care. 2009 Oct;15(5):392-7. doi: 10.1097/MCC.0b013e3283307a4e.

  PMID: 19633546 BACKGROUND

• Kumar A, Haery C, Parrillo JE. Myocardial dysfunction in septic shock. Crit Care Clin. 2000 Apr;16(2):251-87. doi: 10.1016/s0749-0704(05)70110-x.

  PMID: 10768082 BACKGROUND

• 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.

  PMID: 19325359 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

• Kern JW, Shoemaker WC. Meta-analysis of hemodynamic optimization in high-risk patients. Crit Care Med. 2002 Aug;30(8):1686-92. doi: 10.1097/00003246-200208000-00002.

  PMID: 12163777 BACKGROUND

• Lapostolle F, Petrovic T, Catineau J, Lenoir G, Adnet F. Training emergency physicians to perform out-of-hospital ultrasonography. Am J Emerg Med. 2005 Jul;23(4):572. doi: 10.1016/j.ajem.2005.01.008. No abstract available.

  PMID: 16032640 BACKGROUND

• Stewart GM, Nguyen HB, Kim TY, Jauregui J, Hayes SR, Corbett S. Inter-rater reliability for noninvasive measurement of cardiac function in children. Pediatr Emerg Care. 2008 Jul;24(7):433-7. doi: 10.1097/PEC.0b013e31817de143.

  PMID: 18580818 BACKGROUND

• Meyer S, Todd D, Shadboldt B. Assessment of portable continuous wave Doppler ultrasound (ultrasonic cardiac output monitor) for cardiac output measurements in neonates. J Paediatr Child Health. 2009 Jul-Aug;45(7-8):464-8. doi: 10.1111/j.1440-1754.2009.01535.x.

  PMID: 19712182 BACKGROUND

• Critchley LA, Peng ZY, Fok BS, Lee A, Phillips RA. Testing the reliability of a new ultrasonic cardiac output monitor, the USCOM, by using aortic flowprobes in anesthetized dogs. Anesth Analg. 2005 Mar;100(3):748-753. doi: 10.1213/01.ANE.0000144774.42408.05.

  PMID: 15728064 BACKGROUND

• Su BC, Yu HP, Yang MW, Lin CC, Kao MC, Chang CH, Lee WC. Reliability of a new ultrasonic cardiac output monitor in recipients of living donor liver transplantation. Liver Transpl. 2008 Jul;14(7):1029-37. doi: 10.1002/lt.21461.

  PMID: 18581505 BACKGROUND

• He SR, Zhang C, Liu YM, Sun YX, Zhuang J, Chen JM, Madigan VM, Smith BE, Sun X. Accuracy of the ultrasonic cardiac output monitor in healthy term neonates during postnatal circulatory adaptation. Chin Med J (Engl). 2011 Aug;124(15):2284-9.

  PMID: 21933558 BACKGROUND

• Brierley J, Peters MJ. Distinct hemodynamic patterns of septic shock at presentation to pediatric intensive care. Pediatrics. 2008 Oct;122(4):752-9. doi: 10.1542/peds.2007-1979.

  PMID: 18829798 BACKGROUND

• van Lelyveld-Haas LE, van Zanten AR, Borm GF, Tjan DH. Clinical validation of the non-invasive cardiac output monitor USCOM-1A in critically ill patients. Eur J Anaesthesiol. 2008 Nov;25(11):917-24. doi: 10.1017/S0265021508004882. Epub 2008 Jul 24.

  PMID: 18652712 BACKGROUND

• Tan HL, Pinder M, Parsons R, Roberts B, van Heerden PV. Clinical evaluation of USCOM ultrasonic cardiac output monitor in cardiac surgical patients in intensive care unit. Br J Anaesth. 2005 Mar;94(3):287-91. doi: 10.1093/bja/aei054. Epub 2005 Jan 14.

  PMID: 15653709 BACKGROUND

• Chand R, Mehta Y, Trehan N. Cardiac output estimation with a new Doppler device after off-pump coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2006 Jun;20(3):315-9. doi: 10.1053/j.jvca.2005.05.024. Epub 2006 Jan 18.

  PMID: 16750729 BACKGROUND

• Deep A, Goonasekera CD, Wang Y, Brierley J. Evolution of haemodynamics and outcome of fluid-refractory septic shock in children. Intensive Care Med. 2013 Sep;39(9):1602-9. doi: 10.1007/s00134-013-3003-z. Epub 2013 Jun 28.

  PMID: 23812341 BACKGROUND

• Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. doi: 10.1007/s00134-007-0934-2. Epub 2007 Dec 4.

  PMID: 18058085 BACKGROUND

• Zheng ML, Sun X, Zhong J, He SR, Pan W, Pang CC, Sun YX, Liu YM. [Clinical study of neonatal cardiac output measurement methods]. Zhonghua Er Ke Za Zhi. 2013 Jan;51(1):58-63. Chinese.

  PMID: 23527933 BACKGROUND

• 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.

  BACKGROUND

• Lichtenthal PR, Sloniger JA, Copeland JG. (2007) USCOM non-invasive Doppler cardiac output: Are measurements accurate in infants and children? Anesthesiology 107: A1528.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Patel N, Dodsworth M, Mills JF. Cardiac output measurement in newborn infants using the ultrasonic cardiac output monitor: an assessment of agreement with conventional echocardiography, repeatability and new user experience. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F206-11. doi: 10.1136/adc.2009.170704. Epub 2010 Jul 6.

  PMID: 20605971 BACKGROUND

• Nguyen HB, Banta DP, Stewart G, Kim T, Bansal R, Anholm J, Wittlake WA, Corbett SW. Cardiac index measurements by transcutaneous Doppler ultrasound and transthoracic echocardiography in adult and pediatric emergency patients. J Clin Monit Comput. 2010 Jun;24(3):237-47. doi: 10.1007/s10877-010-9240-6. Epub 2010 Jun 20.

  PMID: 20563629 BACKGROUND

• Knirsch W, Kretschmar O, Tomaske M, Stutz K, Nagdyman N, Balmer C, Schmitz A, Bettex D, Berger F, Bauersfeld U, Weiss M. Cardiac output measurement in children: comparison of the Ultrasound Cardiac Output Monitor with thermodilution cardiac output measurement. Intensive Care Med. 2008 Jun;34(6):1060-4. doi: 10.1007/s00134-008-1030-y. Epub 2008 Feb 23.

  PMID: 18297271 BACKGROUND

• Jain S, Allins A, Salim A, Vafa A, Wilson MT, Margulies DR. Noninvasive Doppler ultrasonography for assessing cardiac function: can it replace the Swan-Ganz catheter? Am J Surg. 2008 Dec;196(6):961-7; discussion 967-8. doi: 10.1016/j.amjsurg.2008.07.039.

  PMID: 19095116 BACKGROUND

• Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.

  PMID: 16376782 BACKGROUND

• Krause I, Birk E, Davidovits M, Cleper R, Blieden L, Pinhas L, Gamzo Z, Eisenstein B. Inferior vena cava diameter: a useful method for estimation of fluid status in children on haemodialysis. Nephrol Dial Transplant. 2001 Jun;16(6):1203-6. doi: 10.1093/ndt/16.6.1203.

  PMID: 11390721 BACKGROUND

• Kosiak W, Swieton D, Piskunowicz M. Sonographic inferior vena cava/aorta diameter index, a new approach to the body fluid status assessment in children and young adults in emergency ultrasound--preliminary study. Am J Emerg Med. 2008 Mar;26(3):320-5. doi: 10.1016/j.ajem.2007.07.012.

  PMID: 18358944 BACKGROUND

• Chen L, Kim Y, Santucci KA. Use of ultrasound measurement of the inferior vena cava diameter as an objective tool in the assessment of children with clinical dehydration. Acad Emerg Med. 2007 Oct;14(10):841-5. doi: 10.1197/j.aem.2007.06.040.

  PMID: 17898246 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Meyer S, Todd D, Wright I, Gortner L, Reynolds G. Review article: Non-invasive assessment of cardiac output with portable continuous-wave Doppler ultrasound. Emerg Med Australas. 2008 Jun;20(3):201-8. doi: 10.1111/j.1742-6723.2008.01078.x. Epub 2008 Apr 9.

  PMID: 18400002 BACKGROUND

• Levy JA, Noble VE. Bedside ultrasound in pediatric emergency medicine. Pediatrics. 2008 May;121(5):e1404-12. doi: 10.1542/peds.2007-1816.

  PMID: 18450883 BACKGROUND

• Barnett SB, Ter Haar GR, Ziskin MC, Rott HD, Duck FA, Maeda K. International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. Ultrasound Med Biol. 2000 Mar;26(3):355-66. doi: 10.1016/s0301-5629(00)00204-0.

  PMID: 10773365 BACKGROUND

• Hershkovitz R, Sheiner E, Mazor M. Ultrasound in obstetrics: a review of safety. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):15-8. doi: 10.1016/s0301-2115(01)00469-9.

  PMID: 11803093 BACKGROUND

• Schratz LM, Meyer RA, Schwartz DC. Serial intracoronary ultrasound in children: feasibility, reproducibility, limitations, and safety. J Am Soc Echocardiogr. 2002 Aug;15(8):782-90. doi: 10.1067/mje.2002.119911.

  PMID: 12174347 BACKGROUND

• Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi: 10.1056/NEJM198710223171717. No abstract available.

  PMID: 3657876 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Choong, MD,BCh,MSc

  McMaster University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Departments of Pediatrics and Critical Care

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: March 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2015-11

Locations

CA (1)