Clinical trial NCT04319965: Complications Related to Transpulmonary Thermodilution
Official title: Complications Related to Transpulmonary Thermodilution in the Intensive Care Unit and the Operating Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Hemodynamic Instability
Septic Shock
Acute Respiratory Distress Syndrome
Keywords: Hemodynamic monitoring
Transpulmonary Thermodilution
Intensive care unite
Operating room
Complications of catheters
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in ICU or intermediate care units and in OR, monitoring by TPTD system

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: To describe the incidence of transpulmonary thermodilution related complications
timeFrame: At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation
Secondary outcomes:
measure: Prevalence of theoretical risk factors for these complications.
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Bicetre Hospital
state: Val-de-Marne
Study officials:
affiliation: Medical intensive care unit; Bicêtre Hospital
name: Xavier Monnet, MD.PhD
role: STUDY_CHAIR
References:
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citation: 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.
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citation: 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.
citation: Belda FJ, Aguilar G, Teboul JL, Pestana D, Redondo FJ, Malbrain M, Luis JC, Ramasco F, Umgelter A, Wendon J, Kirov M, Fernandez-Mondejar 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.