- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04800796
Transfer of Standard Operating Procedures in Anesthesiology (QUALI-II)
March 15, 2021 updated by: Marc Kriege, MD, Johannes Gutenberg University Mainz
Evaluation From Didactic and Structural Transfer of Standard Operating Procedures in Anesthesiology
Patients safety and high Quality Performance built up the centre of anesthesiology.
Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.
Study Overview
Detailed Description
The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.
Study Type
Observational
Enrollment (Actual)
60
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
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Germany, D55131
- Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
anesthesia physicians who participating in a Scenario training
Description
Inclusion:
- anesthesia residents
- anesthesia consultants
Exclusion:
- nurses
- students
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 |
Intervention / Treatment |
|---|---|
|
Intervention Group
Intervention Group with audiovisually blended learning concept
|
Receive blended learning before and reading the Standard operating procedure
|
|
Standard group
Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of SOP deviations
Time Frame: 12 minutes after start scenario
|
SOP deviations during scenario training
|
12 minutes after start scenario
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Kriege, MD, PhD, University JG, Mainz
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)
March 1, 2021
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
March 7, 2021
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
March 15, 2021
First Posted (Actual)
March 16, 2021
Study Record Updates
Last Update Posted (Actual)
March 16, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- JohannesGUQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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