Complications Related to Transpulmonary Thermodilution

• Conditions: Critical Illness; Acute Respiratory Distress Syndrome; Hemodynamic Instability; Septic Shock

• Registration Number: NCT04319965
• Lead Sponsor: Bicetre Hospital

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.

Study Timeline

• Study Start: 2020-02-08
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the incidence of transpulmonary thermodilution related complications	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 Outcome Measures

Name	Time	Method
Prevalence of theoretical risk factors for these complications.	Through study completion, up to 1 year	Systematic report of morphologic characteristics, coagulation, immunity

Trial Locations

Locations (1)

Bicetre Hospital; 🇫🇷 Paris, Val-de-Marne, France