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

Recruiting

• Conditions: Structural Similarity Index Measure; Image Interpretation, Computer-Assisted; Learning Curve; Multispectral Optoacoustic Tomography
• Interventions: Device: MSOT measurements

• Registration Number: NCT05773547
• Lead Sponsor: University Hospital Erlangen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-17
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-04-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trainee-video	MSOT measurements	Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction from video.
Professional	MSOT measurements	Two investigators who have performed over 200 MSOT measurements.
Trainee-personal teaching	MSOT measurements	Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received a personal teaching from one professional.
Trainee-instruction in paperform	MSOT measurements	Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction in paperform.

Primary Outcome Measures

Name	Time	Method
Learning curve in MSOT measurements.	5 days	If the quality of MSOT measurements improved with practices.
Different learning curve between professionals and trainees.	5 days	Observe the possible difference between the learning curves in professionals and trainees.

Secondary Outcome Measures

Name	Time	Method
Different learning curve in three different teaching methods	5 days	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.

Trial Locations

Locations (1)

University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery; 🇩🇪 Erlangen, Bavaria, Germany