Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using MSOT

Learning Curve Clinical Trial

Official title:

Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using the Multispectral Optoacoustic Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773547
• Other study ID #: MSOT_Lerneffekt
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2023
• Source: University Hospital Erlangen
• Contact: Ulrich Rother, PD Dr. med.
• Phone: +4991318542028
• Email: ulrich.rother[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to investigate the learning effect in the measurement of micro-circulation in healthy participants using MSOT. The main question it aims to answer are:

If there if a learning effect in MSOT measurement. How long does it takes for the trainees to reach the professional level. Is there a difference between different learning methods? Participants will have to lie on the examination bed while investigator making measurements 7 times in a row on one single location.

Description:

Learning effect of MSOT measurements have been observed by previous studies. Therefore, in this study, we aim to quantify the learning effect with circulation-related parameters (Hb, HbO2, SO2) and the similarity between repeated images (structural similarity index measure, SSIM). The measurement would be repeated by 5 different investigators, two of them are professionals, defined as experience over 200 times of MSOT measurement, while the other three are trainees, who haven't performed any MSOT measurements before and each has received one different teaching method, one receiving personal teaching from a professional, one receiving video instruction and one receiving instructions written in paper form.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

-all those who with the age between 18 and 40 year-old

Exclusion Criteria:

• diabetes mellitus

• hypertension

• cardiovascular diseases

• chronic kidney diseases

• amputation in either lower extremities

• tatoos in either lower extremities

Related Conditions & MeSH terms

• Image Interpretation, Computer-Assisted
• Learning Curve

Intervention

Device:
• MSOT measurements
Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Learning curve in MSOT measurements.	If the quality of MSOT measurements improved with practices.	5 days
Primary	Different learning curve between professionals and trainees.	Observe the possible difference between the learning curves in professionals and trainees.	5 days
Secondary	Different learning curve in three different teaching methods	Three trainees, each received different teaching methods, perform the same measurement on the same participants. The outcome is to observe possible difference in learning curve in these three groups.	5 days