- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319965
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
Status
Recruiting
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
- Name: Xavier Monnet, MD.PhD
- Phone Number: 331 45 21 35 39
- Email: xavier.monnet@aphp.fr
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.
Sponsor
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
- Sakka SG, Reuter DA, Perel A. The transpulmonary thermodilution technique. J Clin Monit Comput. 2012 Oct;26(5):347-53. doi: 10.1007/s10877-012-9378-5. Epub 2012 Jul 18.
- Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
- Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.
- Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291.
- Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.
- Belda FJ, Aguilar G, Teboul JL, Pestana D, Redondo FJ, Malbrain M, Luis JC, Ramasco F, Umgelter A, Wendon J, Kirov M, Fernandez-Mondejar E; PICS Investigators Group. Complications related to less-invasive haemodynamic monitoring. Br J Anaesth. 2011 Apr;106(4):482-6. doi: 10.1093/bja/aeq377. Epub 2010 Dec 26.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A03234-51
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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