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: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 31, 2021
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
- 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
- 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
- Age ≥ 18 years
- Monitoring by a TPTD system (PiCCO2 or VolumeView/EV1000) already planned or set up
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- 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, firstname.lastname@example.org
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