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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04669925
Other study ID # Tsunami
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date January 15, 2022

Study information

Verified date December 2021
Source Mario Negri Institute for Pharmacological Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study has 3 main goals: - to quantitavely describe the Covid-19 impact on the organization and functioning of the Lombardy's emergency system; - to create statistical model able to predict the flow of patients to the emergency room during the epidemic period and their destination (ex: discharge, hospitalization, death); - to value the impact on the non Covid-19 patients, both for their possibility to receive medical treatment and as an outcome on their health


Description:

The aim of this study is to evaluate the impact that Covid-19 had on the Emergency System of Lombardy. For instance, it affected the job organization and the possibility of responding to general health needs. First of all, the study will consider the calls to the Emergency Medical Service, the number of accesses to the Emergency Department, the waiting time before hospitalization, the ED output home (discharge, hospitalization, death, self-discharge before the end of the visit). Secondly, a statistical model will be implemented, in order to predict the number of patients in need of hospitalization for each day during the pandemic period. This model could help the re-organization of the hospital itself in case of a new Covid-19 outbreak. Finally, it will evaluate the impact on non-Covid patients, to see the difference in the mortality trends and their possiblity to be cured in a proper way.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date January 15, 2022
Est. primary completion date January 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - over 18y Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Ospedale Papa Giovanni XXIII Bergamo
Italy Presidio Ospedaliero di Lodi Lodi
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
Italy Ospedale San Carlo Borromeo Milan

Sponsors (1)

Lead Sponsor Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily calls to the Emergency System The number of calls to the Lombardy Emergency System will be evaluated daily during the study period jan 2020 - dec 2020
Primary Daily count of Emergency Department visits The number of people accessing to each ED will be evaluated daily jan 2020 - dec 2020
Primary Daily average boarding time The average time between the end of the ED visit and the hospital admission will be measured daily jan 2020 - dec 2020
Primary Outcome at ED discharge Distribution of the ED outcome (home discharge, hospitalization, death, self-discharge before the end of the visit) jan 2020 - dec 2020
Primary Mortality Daily mortality for any cause jan 2020 - dec 2020
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