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

NCT ID: NCT04347928

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-11-06

Brief Summary

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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

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Conditions

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COVID-19 ARDS Sars-CoV2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thibault Duburcq, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hopital Roger Salengro, CHU Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00957-32

Identifier Type: OTHER

Identifier Source: secondary_id

2020_32

Identifier Type: -

Identifier Source: org_study_id