Complications Related to Transpulmonary Thermodilution (COTRADIL)

May 26, 2022 updated by: Xavier Monnet, Bicetre Hospital

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Val-de-Marne
      • Paris, Val-de-Marne, France, 94270
        • Recruiting
        • Bicetre hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted in ICU or intermediate care units and in OR, monitoring by TPTD system

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Xavier Monnet, MD.PhD, Medical intensive care unit; Bicêtre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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