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NCT04818463 Clinical Trial

Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients

Covid19 Clinical Trial

Official title:
Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04818463
Other study ID # QUALITY COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 31, 2021

Study information
Verified date April 2021
Source Charite University, Berlin, Germany
Contact Claudia Spies, MD, Prof.
Phone +49 30 450 551102
Email claudia.spies@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As part of the internal quality management (QM project), this retrospective cohort study examines the adherence to Standard Operating Procedures (SOP) of the COVID-19 patients treated since January 1st, 2020 to February 28th, 2021 in intensive care units of the Clinic for Anesthesiology m.S. operative intensive care medicine CCM / CVK.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - During the intensive care stay with SARS-CoV-2 infected intensive care patients of the Charité - Universitätsmedizin Berlin, admitted to the intensive care units of the Department of Anesthesiology and operative intensive care medicine (CCM / CVK) - Treatment period: 01/01/2020 to 02/28/2021 - At least 18 years old Exclusion Criteria: • Incomplete electronic documentation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Campus Virchow-Klinikum Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary SOP "Analgesia, sedation, delirium and pain therapy" SOP adherence to the selected SOP "Analgesia, sedation, delirium and pain therapy". Process: daily implementation yes / no - yes> 70% 01.01.2020 - 28.02.2021
Secondary SOP "Treatment of acute respiratory distress syndrome (ARDS)" SOP adherence to the selected SOP "Treatment of acute respiratory distress syndrome (ARDS)" Process: daily implementation yes / no - yes> 70% 01.01.2020 - 28.02.2021
Secondary SOP "Infectious treatment" SOP adherence to the selected SOP "Infectious treatment" Process: daily implementation yes / no - yes> 70% 01.01.2020 - 28.02.2021
Secondary SOP "Weaning" SOP adherence to the selected SOP "Weaning" 01.01.2020 - 28.02.2021
Secondary SOP "Nutrition" SOP adherence to the selected SOP "Nutrition" Process: daily implementation yes / no - yes> 70% 01.01.2020 - 28.02.2021
Secondary SOP "Sepsis" SOP adherence to the selected SOP "Sepsis" Process: daily implementation yes / no - yes> 70% 01.01.2020 - 28.02.2021
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