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OpenTrials
Completed

NCT Number: NCT04376905

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Changes of Pulmonary Vascular Permeability Index

    Time frame: 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

  2. Changes of pulmonary compliance

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

    Changes of pulmonary compliance (ml/mmHg)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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)

Acronym: PiCCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 6, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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