Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19

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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Key information

Conditions

COVID-19 ARDS Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

intrapulmonary shunt ratio

Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation

Secondary outcomes

Evolution of respiratory variables

Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation

Evaluation of PaO2 variation between in a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)
Evolution of respiratory variables

Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation

Evaluation of PaCO2 variation between in a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)
Evolution of hemodynamic stability variables

Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation

Evaluation of cardiac output variation between a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: PHYSIO-COVID

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 15, 2020
Registry last updated: Nov 17, 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.

Published trials that share one or more normalized conditions with this study.

Completed