NCT03893513

Brief Summary

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

March 26, 2019

Last Update Submit

June 17, 2019

Conditions

Hemodynamic Monitoring

Keywords

Bio-impedanceHaemodynamic monitoringPulse contour analysiskidney transplantation

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic correlation

    Correlation between hemodynamic measured between devices: cardiac index, stroke volume index, systemic vascular resistance index, stroke volume index

    Intraoperative

Secondary Outcomes (4)

  • Changes in hemodynamic profiles: Cardiac Index

    Intraoperative

  • Changes in hemodynamic profiles: Stroke Volume Index

    Intraoperative

  • Changes in hemodynamic profiles: Systemic Vascular Resistance Index

    Intraoperative

  • Changes in hemodynamic profiles: Stroke Volume Variation

    Intraoperative

Interventions

Transthoracic Electrical BioimpedanceDEVICE

Non-invasive hemodynamic monitor

Also known as: ICON
Pulse Contour AnalysisDEVICE

Invasive hemodynamic monitor

Also known as: EV1000

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients planned to undergo elective kidney transplantation surgery as recipient

You may qualify if:

  • BMI 18.5 - 35 kg/m\^2

You may not qualify if:

  • Heart function abnormalities (arrhythmia, AV block, using pacemaker, severe aorta stenosis)
  • Morbid obesity
  • Bradycardia (\< 50 bpm)
  • Tachycardia (\> 110 bpm)
  • refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (27)

  • Vincent JL, Pelosi P, Pearse R, Payen D, Perel A, Hoeft A, Romagnoli S, Ranieri VM, Ichai C, Forget P, Della Rocca G, Rhodes A. Perioperative cardiovascular monitoring of high-risk patients: a consensus of 12. Crit Care. 2015 May 8;19(1):224. doi: 10.1186/s13054-015-0932-7.

    PMID: 25953531BACKGROUND

  • Joosten A, Huynh T, Suehiro K, Canales C, Cannesson M, Rinehart J. Goal-Directed fluid therapy with closed-loop assistance during moderate risk surgery using noninvasive cardiac output monitoring: A pilot study. Br J Anaesth. 2015 Jun;114(6):886-92. doi: 10.1093/bja/aev002. Epub 2015 Feb 17.

    PMID: 25690834BACKGROUND

  • Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.

    PMID: 24842135BACKGROUND

  • Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.

    PMID: 20966436BACKGROUND

  • Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.

    PMID: 9361539BACKGROUND

  • Edison E, Pearse R. Goal directed therapy in the perioperative setting: What is the evidence? In: Paradise Lost and the Cosmological Revolution. 2014.

    BACKGROUND

  • Aya HD, Cecconi M, Rhodes A. Perioperative Haemodynamic Optimisation. Turk J Anaesthesiol Reanim. 2014 Apr;42(2):56-65. doi: 10.5152/TJAR.2014.2220141. Epub 2014 Apr 1.

    PMID: 27366392BACKGROUND

  • Saugel B, Cecconi M, Wagner JY, Reuter DA. Noninvasive continuous cardiac output monitoring in perioperative and intensive care medicine. Br J Anaesth. 2015 Apr;114(4):562-75. doi: 10.1093/bja/aeu447. Epub 2015 Jan 16.

    PMID: 25596280BACKGROUND

  • Alhashemi JA, Cecconi M, Hofer CK. Cardiac output monitoring: an integrative perspective. Crit Care. 2011;15(2):214. doi: 10.1186/cc9996. Epub 2011 Mar 22. No abstract available.

    PMID: 21457508BACKGROUND

  • Allaria B, Poli DM CD. Perioperative hemodynamic monitoring: invasive vs. non-invasive. In: Anesthesia, Pain, Intensive Care and Emergency Medicine - APICE. Italy: Springer-Verlag; 2013. p. 291-9.

    BACKGROUND

  • Boyd O, Jackson N. How is risk defined in high-risk surgical patient management? Crit Care. 2005 Aug;9(4):390-6. doi: 10.1186/cc3057. Epub 2005 Feb 9.

    PMID: 16137389BACKGROUND

  • Goldfarb D, Poggio E. Etiology, pathogenesis, and management of renal failure. In: Wein A, Kavoussi L, Novick A, Partin A, Peters C, editors. Campbell-Walsh Urology. 10th ed. Philadelphia: Elsevier Saunders; 2012. p. 1226-53.

    BACKGROUND

  • Angelotti T, Lemmens H. Liver/Kidney/Pancreas transplantation. In: Jaffe R, Schmiesing C, Golianu B, editors. Anesthesiologist's Manual of Surgical Procedures. 5th editio. Philadelphia: Wolters Kluwer Health; 2014. p. 1097-100.

    BACKGROUND

  • Darovic G. Hemodynamic monitoring: invasive and noninvasive clinical applications. 3rd ed. Darovic G, editor. Philadelphia: W.B. Saunders; 2002. 191-260 p.

    BACKGROUND

  • Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1093/bja/aet116. Epub 2013 Apr 26.

    PMID: 23625132BACKGROUND

  • Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/cc11366.

    PMID: 22647561BACKGROUND

  • Marque S, Cariou A, Chiche JD, Squara P. Comparison between Flotrac-Vigileo and Bioreactance, a totally noninvasive method for cardiac output monitoring. Crit Care. 2009;13(3):R73. doi: 10.1186/cc7884. Epub 2009 May 19.

    PMID: 19454009BACKGROUND

  • Connor C. Commonly used monitoring techniques. In: Barash P, Cullen B, Stoelting R, Cahalan M, Stock C, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lippincott Williams&Wilkins; 2013. p. 712-20.

    BACKGROUND

  • Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.

    PMID: 25276302BACKGROUND

  • Porhomayon J, El-Solh A, Papadakos P, Nader ND. Cardiac output monitoring devices: an analytic review. Intern Emerg Med. 2012 Apr;7(2):163-71. doi: 10.1007/s11739-011-0738-9. Epub 2011 Dec 7.

    PMID: 22147648BACKGROUND

  • Chamos C, Vele L, Hamilton M, Cecconi M. Less invasive methods of advanced hemodynamic monitoring: principles, devices, and their role in the perioperative hemodynamic optimization. Perioper Med (Lond). 2013 Sep 17;2(1):19. doi: 10.1186/2047-0525-2-19.

    PMID: 24472443BACKGROUND

  • Peyton PJ, Chong SW. Minimally invasive measurement of cardiac output during surgery and critical care: a meta-analysis of accuracy and precision. Anesthesiology. 2010 Nov;113(5):1220-35. doi: 10.1097/ALN.0b013e3181ee3130.

    PMID: 20881596BACKGROUND

  • Frolich M. Cardiovascular monitoring. In: Butterworth J, Mackey D, Wasnick J, editors. Clinical Anesthesiology. 5th ed. New York: McGraw-Hill; 2013. p. 87-122.

    BACKGROUND

  • Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.

    PMID: 17039348BACKGROUND

  • Fellahi JL, Caille V, Charron C, Deschamps-Berger PH, Vieillard-Baron A. Noninvasive assessment of cardiac index in healthy volunteers: a comparison between thoracic impedance cardiography and Doppler echocardiography. Anesth Analg. 2009 May;108(5):1553-9. doi: 10.1213/ane.0b013e31819cd97e.

    PMID: 19372335BACKGROUND

  • Sodolski T, Kutarski A. Impedance cardiography: A valuable method of evaluating haemodynamic parameters. Cardiol J. 2007;14(2):115-26.

    PMID: 18651447BACKGROUND

  • Monnet X, Teboul JL. Minimally invasive monitoring. Crit Care Clin. 2015 Jan;31(1):25-42. doi: 10.1016/j.ccc.2014.08.002.

    PMID: 25435477BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Anesthesiologist Consultant

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

March 12, 2019

Primary Completion

April 12, 2019

Study Completion

May 12, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

ID(1)