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

Completed

• Conditions: COVID-19; ARDS; Sars-CoV2

• Registration Number: NCT04347928
• Lead Sponsor: University Hospital, Lille

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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Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Study Start: 2020-04-20
• Status Verified: 2020-05
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intrapulmonary shunt ratio	during ICU stay, in the first 72 hours of mechanical ventilation initiation

Secondary Outcome Measures

Name	Time	Method
Evolution of respiratory variables	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	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)

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France