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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT04376905

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia Acute Respiratory Distress Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Sep 30, 2020

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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