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

NCT04376905 | Completed

• 1 other identifier: RECHMPL20_0193
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19; Pneumonia; Acute Respiratory Distress Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes of Extra Vascular Lung Water

  EVLW (ml/kg) measured by a PiCCO device using TPTD thermodilution

  Since intubation at day 0 and measured repetitively by 6 hours until day 3

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 critically ill patients

You may qualify if:

• COVID-19 critically ill patients
• Invasive mechanical ventilation

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Kada KLOUCHE, MD PhD

  UH Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 6, 2020
• Study Start: April 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)