Clinical trial NCT04347928: Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19
Official title: Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
ARDS
Sars-CoV2
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient hospitalized in ICU mechanically ventilated for less than 72 hours

Brief summary: In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. It therefore seems essential to rigorously study these modifications, as they have been studied in the past for ARDS.

The aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by COVID-19 in mechanically ventilated patients

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Eligibility criteria: Inclusion Criteria:

* hospitalized in intensive care for a SARS-CoV2 infection
* requiring invasive ventilation,
* intubated for less than 72 hours with PaO2/FiO2 ratio \< 200 mmHg

Exclusion Criteria:

* Patient mechanically ventilated for 72 hours or more
* Patient with documented respiratory co-infection
* Patient with a contraindication to pulmonary artery catheter insertion: High risk of bleeding, pre-existing high degree of atrioventricular heart block , Pace Maker
* Patient with spontaneous ventilation
* Patient with severe ARDS with static compliance of the respiratory system \< 20 mL/cmH2O
* Patient with severe ARDS with indication of prone positioning at inclusion.
* Patient with a cardiac condition that renders the measurement of pulmonary artery occlusion pressure uninterpretable as a surrogate for left ventricle end diastolic pressure (severe mitral insufficiency, severe mitral stricture, severe aortic insufficiency).
* Patient with intracardiac shunt
* Patient with ECMO
* Minors and pregnant women.
* Person not affiliated to or not benefiting from a social security scheme.

Primary outcomes:
measure: intrapulmonary shunt ratio
timeFrame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Secondary outcomes:
measure: Evolution of respiratory variables
timeFrame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
measure: Evolution of respiratory variables
timeFrame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
measure: Evolution of hemodynamic stability variables
timeFrame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Thibault Duburcq, MD
role: PRINCIPAL_INVESTIGATOR
References: