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

COVID-19 Clinical Trial

— PHYSIO-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347928
• Other study ID #: 2020_32
• Secondary ID: 2020-A00957-32
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: November 6, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Sars-CoV2

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intrapulmonary shunt ratio		during ICU stay, in the first 72 hours of mechanical ventilation initiation
Secondary	Evolution of respiratory variables	Evaluation of PaO2 variation between in a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)	during ICU stay, in the first 72 hours of mechanical ventilation initiation
Secondary	Evolution of respiratory variables	Evaluation of PaCO2 variation between in a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)	during ICU stay, in the first 72 hours of mechanical ventilation initiation
Secondary	Evolution of hemodynamic stability variables	Evaluation of cardiac output variation between a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)	during ICU stay, in the first 72 hours of mechanical ventilation initiation