Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04376905

Acronym

PiCCOVID

Enrollment

Registered

2020-05-06

Start date

2020-04-01

Completion date

2020-09-30

Last updated

2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, COVID-19, Pneumonia

Keywords

ARDS, ICU, Transpulmonary thermodilution, Extravascular lung water, Pulmonary Vascular Permeability Index

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Changes of Extra Vascular Lung Water	Since intubation at day 0 and measured repetitively by 6 hours until day 3	EVLW (ml/kg) measured by a PiCCO device using TPTD thermodilution

Secondary

Measure	Time frame	Description
Changes of Pulmonary Vascular Permeability Index	Since intubation at day 0 and measured repetitively by 6 hours until day 3	PVPI measured by a PiCCO device using TPTDventilation, duration of ICU length of stay, ICU mortality
Changes of pulmonary compliance	Since intubation at day 0 and measured repetitively by 6 hours until day 3	Changes of pulmonary compliance (ml/mmHg)

Countries

France

Outcome results