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

October 25, 2024 updated by: Claudia Spies, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

162

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

  • Germany
      • Berlin, Germany, 13353
        • Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Campus Virchow-Klinikum

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

Sampling Method

Probability Sample

Study Population

During the intensive care stay with SARS-CoV-2 infected intensive care adult patients

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOP "Analgesia, sedation, delirium and pain therapy"
Time Frame: 01.01.2020 - 28.02.2021
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOP "Treatment of acute respiratory distress syndrome (ARDS)"
Time Frame: 01.01.2020 - 28.02.2021
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
SOP "Infectious treatment"
Time Frame: 01.01.2020 - 28.02.2021
SOP adherence to the selected SOP "Infectious treatment" Process: daily implementation yes / no - yes> 70%
01.01.2020 - 28.02.2021
SOP "Weaning"
Time Frame: 01.01.2020 - 28.02.2021
SOP adherence to the selected SOP "Weaning"
01.01.2020 - 28.02.2021
SOP "Nutrition"
Time Frame: 01.01.2020 - 28.02.2021
SOP adherence to the selected SOP "Nutrition" Process: daily implementation yes / no - yes> 70%
01.01.2020 - 28.02.2021
SOP "Sepsis"
Time Frame: 01.01.2020 - 28.02.2021
SOP adherence to the selected SOP "Sepsis" Process: daily implementation yes / no - yes> 70%
01.01.2020 - 28.02.2021

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

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 1, 2021

Primary Completion (Actual)

June 21, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUALITY COVID-19

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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