ARDS Caused by COVID-19

April 29, 2020 updated by: Carlos Ferrando Ortolá, Hospital Clinic of Barcelona

Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19

Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a multicenter, prospective, observational study in consecutive, mechanically ventilated patients with ARDS caused by COVID-19 (as defined by the Berlin criteria and confirmed COVID-19 infection in a respiratory tract sample), admitted into a network of 27 Spanish and Andorran intensive care units (ICUs). Clinical features, ventilatory management, and clinical outcomes will be examined

Study Type

Observational

Enrollment (Anticipated)

500

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

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Ricard Mellado
        • Contact:

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

Critically ill patients with acute respiratory failure requiring invasive mechanical ventilation

Description

Inclusion Criteria:

  • aged 18 years or older
  • intubated and mechanically ventilated
  • confirmed COVID-19 infection in a respiratory tract sample
  • acute onset of ARDS, as defined by the Berlin criteria

Exclusion Criteria:

  • patients with non-confirmed SARS-CoV-2 infection according to WHO guidance
  • patients with no information on respiratory parameters
  • non- intubated patients

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
Discontinuation from mechanical ventilation
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

Collaborators

Ubikare company

Investigators

  • Principal Investigator: Carlos Ferrando, Medical Research and Clinical Consulting

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 12, 2020

Primary Completion (ACTUAL)

April 21, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (ACTUAL)

April 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 ARDS

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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