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Clinical Trials/NCT04376905
NCT04376905
Completed
Not Applicable

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)

University Hospital, Montpellier1 site in 1 country30 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
University Hospital, Montpellier
Enrollment
30
Locations
1
Primary Endpoint
Changes of Extra Vascular Lung Water
Status
Completed
Last Updated
5 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes of Extra Vascular Lung Water

Time Frame: 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 Outcomes

  • Changes of Pulmonary Vascular Permeability Index(Since intubation at day 0 and measured repetitively by 6 hours until day 3)
  • Changes of pulmonary compliance(Since intubation at day 0 and measured repetitively by 6 hours until day 3)

Study Sites (1)

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