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

NCT04347928 | Completed

• 2 other identifiers: 2020_322020-A00957-32
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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 .

Conditions

COVID-19; ARDS; Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• intrapulmonary shunt ratio

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

Secondary Outcomes (3)

• Evolution of respiratory variables

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

• Evolution of respiratory variables

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

• Evolution of hemodynamic stability variables

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient hospitalized in ICU mechanically ventilated for less than 72 hours

You may qualify if:

• hospitalized in intensive care for a SARS-CoV2 infection
• requiring invasive ventilation,
• intubated for less than 72 hours with PaO2/FiO2 ratio \< 200 mmHg

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thibault Duburcq, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: April 20, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-05

Locations

FR (1)