Covid19NCT04818463
Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients
An observational study of Covid19, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 162 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the intensive care stay with SARS-CoV-2 infected intensive care adult patients
Who may be able to join
- 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
Who cannot join
- Incomplete electronic documentation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Campus Virchow-Klinikum
Berlin, 13353
About this study
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.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 01.01.2020 - 28.02.2021
Secondary outcomes (5)
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%
Measured: 01.01.2020 - 28.02.2021
SOP "Infectious treatment"
SOP adherence to the selected SOP "Infectious treatment" Process: daily implementation yes / no - yes> 70%
Measured: 01.01.2020 - 28.02.2021
SOP "Weaning"
SOP adherence to the selected SOP "Weaning"
Measured: 01.01.2020 - 28.02.2021
SOP "Nutrition"
SOP adherence to the selected SOP "Nutrition" Process: daily implementation yes / no - yes> 70%
Measured: 01.01.2020 - 28.02.2021
SOP "Sepsis"
SOP adherence to the selected SOP "Sepsis" Process: daily implementation yes / no - yes> 70%
Measured: 01.01.2020 - 28.02.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818463
- Sponsor's protocol ID
- QUALITY COVID-19
- Status last verified
- Oct 2024
- First submitted
- 18 Mar 2021
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04818463
- Acronym / sponsor ID
- QUALITY COVID-19
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the intensive care stay with SARS-CoV-2 infected intensive care adult patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Incomplete electronic documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
5 secondary outcomes
SOP "Treatment of acute respiratory distress syndrome (ARDS)"
Time frame: 01.01.2020 - 28.02.2021
SOP "Infectious treatment"
Time frame: 01.01.2020 - 28.02.2021
SOP "Weaning"
Time frame: 01.01.2020 - 28.02.2021
SOP "Nutrition"
Time frame: 01.01.2020 - 28.02.2021
SOP "Sepsis"
Time frame: 01.01.2020 - 28.02.2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOP "Analgesia, sedation, delirium and pain therapy" (time frame: 01.01.2020 - 28.02.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.