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

November 16, 2020 updated by: University Hospital, Lille

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

.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hopital Roger Salengro, CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient hospitalized in ICU mechanically ventilated for less than 72 hours

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intrapulmonary shunt ratio
Time Frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
during ICU stay, in the first 72 hours of mechanical ventilation initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
during ICU stay, in the first 72 hours of mechanical ventilation initiation
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)
during ICU stay, in the first 72 hours of mechanical ventilation initiation
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)
during ICU stay, in the first 72 hours of mechanical ventilation initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

November 6, 2020

Study Completion (Actual)

November 6, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_32
  • 2020-A00957-32 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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