The Critical Care Response to the COVID-19 Pandemic in Madrid (Tetrix)

May 26, 2020 updated by: Miguel Sanchez Garcia, Hospital San Carlos, Madrid

The Critical Care Resources Adaptation to the SARS-CoV-2 Pandemic in Madrid

Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19

Study Overview

Status

Unknown

Conditions

Detailed Description

Background

The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.

Methods

The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients admitted to ICUs in Madrid for COVID-19

Description

Inclusion Criteria:

  • Admitted to ICU in Madrid with COVID-19

Exclusion Criteria:

  • Admitted to ICU without COVID-19

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

Cohorts and Interventions

Group / Cohort
Transferred patients
A subgroup of Critically ill intubated patients with COVID-19 associated ARDS were transferred from overwhelmed ICUs to other with available free beds
Matched Non-transferred patients
A subgroup from the global cohort, matched for risk factors will be compared with transferred patients for outcome variables

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 9 weeks
ICU mortality
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: 9 weeks
From admission to discharge or death
9 weeks

Collaborators and Investigators

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

Sponsor

Hospital San Carlos, Madrid

Collaborators

FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

Investigators

  • Principal Investigator: Miguel Sánchez García, MD, Hospital San Carlos, Madrid

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 24, 2020

Primary Completion (ANTICIPATED)

May 31, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Madrid COVID Tetrix

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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