Complications Related to Transpulmonary Thermodilution

Overview

The transpulmonary thermodilution is commonly used in patients with acute circulatory failure in the intensive care unit and for monitoring surgical patients at high risk. However, the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution has not been completely reported yet.

Full Title of Study: “Complications Related to Transpulmonary Thermodilution in the Intensive Care Unit and the Operating Room”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2021

Detailed Description

Transpulmonary thermodilution (TPTD) is a technique used for haemodynamic monitoring. It consists of a monitor device which is connected to two catheters. One is a catheter inserted into the superior vena cava (internal jugular or subclavian), which is a standard catheter commonly used in patients with acute circulatory failure. The other one is a thermistor-tipped arterial catheter, which is inserted through the femoral route (the tip stands in the iliac artery), which allows the measurement of blood temperature. Catheters designed for the radial, brachial and humeral arteries also exist. TPTD allows the computation of cardiac output from the thermodilution curve recorded by the thermistor-tipped femoral arterial catheter. As an advanced cardiac output monitoring technique, it provides several important haemodynamic variables. It can be used in the intensive care unit (ICU) and in the operating room (OR). Two TPTD systems are now on the market. The PiCCO2 system (Pulsion Medical Systems, member of the Getinge Group, Feldkirchen, Germany) and the VolumeView/EV1000 system (Edwards Lifesciences, Irvine, United States of America). This study is designed to investigate the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution.

Clinical Trial Outcome Measures

Primary Measures

  • To describe the incidence of transpulmonary thermodilution related complications
    • Time Frame: At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation
    • Systematic report of mechanical, haemorragic and infections complications

Secondary Measures

  • Prevalence of theoretical risk factors for these complications.
    • Time Frame: Through study completion, up to 1 year
    • Systematic report of morphologic characteristics, coagulation, immunity

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years
  • Monitoring by a TPTD system (PiCCO2 or VolumeView/EV1000) already planned or set up

Exclusion Criteria

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bicetre Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xavier Monnet, Professor Xavier Monnet MD. PhD. – Bicetre Hospital
  • Overall Official(s)
    • Xavier Monnet, MD.PhD, Study Chair, Medical intensive care unit; Bicêtre Hospital
  • Overall Contact(s)
    • Xavier Monnet, MD.PhD, 331 45 21 35 39, xavier.monnet@aphp.fr

References

Sakka SG, Reuter DA, Perel A. The transpulmonary thermodilution technique. J Clin Monit Comput. 2012 Oct;26(5):347-53. doi: 10.1007/s10877-012-9378-5. Epub 2012 Jul 18. Review.

Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5. Review.

Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.

Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring–a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291. Review.

Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

Belda FJ, Aguilar G, Teboul JL, Pestaña D, Redondo FJ, Malbrain M, Luis JC, Ramasco F, Umgelter A, Wendon J, Kirov M, Fernández-Mondéjar E; PICS Investigators Group. Complications related to less-invasive haemodynamic monitoring. Br J Anaesth. 2011 Apr;106(4):482-6. doi: 10.1093/bja/aeq377. Epub 2010 Dec 26. Review.

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