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Clinical Trials/NCT04319965
NCT04319965
Unknown
Not Applicable

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

Bicetre Hospital1 site in 1 country2,000 target enrollmentFebruary 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Bicetre Hospital
Enrollment
2000
Locations
1
Primary Endpoint
To describe the incidence of transpulmonary thermodilution related complications
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2020
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bicetre Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xavier Monnet

Professor Xavier Monnet MD. PhD.

Bicetre Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Prevalence of theoretical risk factors for these complications.(Through study completion, up to 1 year)

Study Sites (1)

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