Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (RECOP)

October 6, 2021 updated by: University Hospital, Toulouse

Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (Unit "COVID Possible")

This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units.

The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units.

This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1860

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
      • Toulouse, France, 31000
        • University Hospital of Toulouse

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

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial

Description

Inclusion Criteria:

  • All patients over the age of 15 admitted to the RECOP unit for dyspnea

Exclusion Criteria:

  • Patient admitted to shock for respiratory distress requiring immediate respiratory support.
  • Patient under justice safeguard

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
Measure Description
Time Frame
Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19
Time Frame: 30 days
The virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a predictive model of the risk of being COVID for patients admitted to the emergency room for dyspnea
Time Frame: 0 days
demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor
0 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological status
Time Frame: 30 days
Virological status will be collected by a phone call at the patient
30 days
Mortality status
Time Frame: 30 days
Mortality status will be collected by a phone call at the patient
30 days

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Frédéric Balen, MD, University Hospital of Toulouse

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 13, 2020

Primary Completion (ACTUAL)

June 5, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (ACTUAL)

May 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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