Clinical trial NCT04376905: Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)
Official title: Assessment of Extra Vascular Lung Water and Pulmonary Permeability by Transpulmonary Thermodilution in Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pneumonia
Acute Respiratory Distress Syndrome
Keywords: ARDS
ICU
Transpulmonary thermodilution
Extravascular lung water
Pulmonary Vascular Permeability Index
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 critically ill patients

Brief summary: Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.

EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2.

Based on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns:

1. Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.
2. Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI.


Eligibility criteria: Inclusion criteria:

* COVID-19 critically ill patients
* Invasive mechanical ventilation

Exclusion criteria:

* Age under 18
* Pregnancy
* Legally protected adults
* Contra-indication of using PiCCO device: jugular venous thrombosis, or severe chronic femoral/iliac artery occlusive disease

Primary outcomes:
measure: Changes of Extra Vascular Lung Water
timeFrame: Since intubation at day 0 and measured repetitively by 6 hours until day 3
Secondary outcomes:
measure: Changes of Pulmonary Vascular Permeability Index
timeFrame: Since intubation at day 0 and measured repetitively by 6 hours until day 3
measure: Changes of pulmonary compliance
timeFrame: Since intubation at day 0 and measured repetitively by 6 hours until day 3
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Kada KLOUCHE, MD PhD
role: STUDY_DIRECTOR
References: