Analysis of microcirculation measurements by novice users trained by a standardized interactive tutorial – an inter-observer variability study
Organizational Data
- DRKS-ID:
- DRKS00007937
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-03-27
- Last update in DRKS:
- 2015-03-27
- Registration type:
- Retrospective
Acronym/abbreviation of the study
NOVA
URL of the study
No Entry
Brief summary in lay language
The analysis of videomicroscopic recordings of the microcirculation (e.g., the blood circulation under the tongue = sublingual microcirculation) is time-consuming and requires an experienced observer in order to obtain reproducible results. Aim of the study is to evaluate the success of a standardized, inter-active training of novice users of the method. We will recruit medical students and residents, provide the standardized, inter-active tutorial and ask them to analyze a standard video recording of the sublingual microcirculation. The result of their analysis will be compared with the results of experts. Our hypothesis is that novice observers trained by our standard, inter-active tutorial are able to generate reproducible results.
Brief summary in scientific language
The analysis of videomicroscopic recordings of the sublingual microcirculation is time-consuming and requires an experienced observer in order to obtain reproducible results. Aim of the study is to evaluate the success of a standardized, inter-active training of novice users of the method. We will recruit medical students and residents, provide the standardized, inter-active tutorial and ask them to analyze a standard video recording of the sublingual microcirculation. The result of their analysis will be compared with the results of experts. Our hypothesis is that novice observers trained by our standard, inter-active tutorial are able to generate reproducible results.
Health condition or problem studied
- Free text:
- microcirculation analysis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Novice users (medical personnel) trained by a 45 minutes standardized interactive tutorial
Endpoints
- Primary outcome:
- Interrater-reliability (novice users vs. experts)
- Secondary outcome:
- time needed for analysis
Study Design
- Purpose:
- Other
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Canada
- Czechia
- Estonia
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Charité Berlin
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2012-08-22
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2012-08-31
- Target Sample Size:
- 20
- Final Sample Size:
- 20
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Medical personnel (nurses, medical students, residents)
Exclusion Criteria
microcirculation experts
Addresses
Primary Sponsor
- Address:
- Charité Campus Virchow-KlinikumAugustenburger Platz 113353 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité Campus Virchow-KlinikumProf. Dr. Christian LehmannAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 01703013045
- Fax:
- 01703013045
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Contact for Public Queries
- Address:
- Charité Campus Virchow-KlinikumProf. Dr. Christian LehmannAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 01703013045
- Fax:
- 01703013045
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Principal Investigator
- Address:
- Charité Campus Virchow-KlinikumProf. Dr. Christian LehmannAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 01703013045
- Fax:
- 01703013045
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Charité Campus Virchow-KlinikumAugustenburger Platz 113353 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-04-11
- Ethics committee number:
- EA1/181/12
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-08-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry