Comparison of lung water in COVID-19 patients and other patients with acute respiratory failure

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Rapid progression of inflammation results in a substantial number of COVID-19 patients requiring mechanical ventilation. In these most severely ill patients, computed tomography of the chest demonstrates a typical pattern which is suggestive to a degree that it is disease-defining, even if the SARS-COV-2 PCR test is negative.
Extravascular lung water index (EVLWI) is a marker of pulmonary oedema. Single indicator transpulmonary thermodilution (TPTD) provides bedside measurement of EVLWI. Several studies demonstrated significant and independent association of EVLWI and its changes over time with mortality. A recent study in a non-COVID-19 cohort with ARDS (see ISRCTN32938630) suggests better and earlier prediction of 28-days-mortality compared to traditional scores grading the severity of ARDSARDS. Furthermore, TPTD-monitoring „per se“ was independently associated with a lower mortality.
However, pathology of COVID-19 is not fully understood, and there is a lack of data on EVLWI and other TPTD-parameters from COVID-19-patients.
Therefore, it is the aim of this study to measure EVLWI in patients with COVID-19 and to compare these findings to EVLWI from a recent non-COVID-19 cohort with ARDS.
As secondary endpoints we will also compare other haemodynamic parameters between COVID-19 and non-COVID-19 patients.

Who can participate?
Adults with COVID-19 and ARDS according to the Berlin definition

What does the study involve?
From the day of intubation, TPTD (PiCCO, Pulsion Medical Systems, Germany) will be performed daily to derive EVLWI, Cardiac Index CI and the preload marker global end-diastolic volme index GEDVI. Furthermore, all other parameters derived from the PiCCO-measurement will be documented.

What are the possible benefits and risks of participating in the study?
The possible benefit is a very thorough analysis and monitoring of pulmonary and haemodynamic parameters. There are no additional risks to participants due to the observational design of the study.

Where is the study run from?
General Intensive Care Unit R3a (2/11) of Munich University Hospital (Germany)

When is the study starting and how long is it expected to run for?
March 2020 to April 2020

Who is funding the study?
Technical University of Munich (Germany)

Who is the main contact?
Prof. Wolfgang Huber
Wolfgang.Huber@tum.de

Contact information

Prof Wolfgang Huber
Scientific

Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Technische Universität München
Ismaningerstr. 22
Munich
D-81675
Germany

ORCID ID	0000-0001-9086-7908
Phone	+49 89 4140 2214
Email	wolfgang.huber@mri.tum.de

Study information

Eligibility

Locations

Countries of recruitment

• Germany

Study participating centre

Sponsor information

Klinikum der Universität München
University/education

Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Technische Universität München
Ismaninger Straße 22
Munich
D-81675
Germany

Phone	+49 89 4140 2251
Email	RolandM.Schmid@mri.tum.de
Website	http://www.gdit.edu.cn/
"ROR"	https://ror.org/02jet3w32

Funders

Funder type

University/education

Results and Publications

Study outputs

Additional files

ISRCTN10077335_PIS_Mar2020.pdf

uploaded 18/05/2020

Editorial Notes

12/06/2023: Publication reference added.
16/03/2021: Preprint reference added.
18/05/2020: The participant information sheet was uploaded as an additional file.
06/04/2020: Trial’s existence confirmed by Ethikkommission der Technischen Universität München