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Complications Related to Transpulmonary Thermodilution

Complications Related to Transpulmonary Thermodilution in the Intensive Care Unit and the Operating Room

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04319965
Acronym
COTRADIL
Enrollment
2000
Registered
2020-03-24
Start date
2020-02-08
Completion date
2023-06-30
Last updated
2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Critical Illness, Hemodynamic Instability, Septic Shock

Keywords

Hemodynamic monitoring, Transpulmonary Thermodilution, Intensive care unite, Operating room, Complications of catheters

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.

Interventions

None listed

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
To describe the incidence of transpulmonary thermodilution related complicationsAt the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situationSystematic report of mechanical, haemorragic and infections complications

Secondary

MeasureTime frameDescription
Prevalence of theoretical risk factors for these complications.Through study completion, up to 1 yearSystematic report of morphologic characteristics, coagulation, immunity

Countries

France

Contacts

Primary ContactXavier Monnet, MD.PhD
xavier.monnet@aphp.fr331 45 21 35 39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026