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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Learning Curve; Image Interpretation, Computer-Assisted; Multispectral Optoacoustic Tomography; Structural Similarity Index Measure
• Intervention / Treatment: Device: MSOT measurements

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ulrich Rother, PD Dr. med.; Phone Number: +4991318542028; Email: ulrich.rother@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
      • Contact: Ulrich Rother, Dr. med.; Phone Number: +4991318542028; Email: ulrich.rother@uk-erlangen.de
      • Contact: Werner Lang, Prof. Dr. med.; Phone Number: +4991318532968; Email: werner.lang@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The volunteers would be recruited in the clinic where the research takes place, by posters and public speeches. T

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Professional; Two investigators who have performed over 200 MSOT measurements.	Device: MSOT measurements; Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses
Trainee-personal teaching; Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received a personal teaching from one professional.	Device: MSOT measurements; Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses
Trainee-video; Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction from video.	Device: MSOT measurements; Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses
Trainee-instruction in paperform; Trainees are defined as who haven't performed any MSOT measurement. In this cohort, one trainee received instruction in paperform.	Device: MSOT measurements; Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Multispectral Optoacoustic Tomography; MSOT; Learning Curve; Learning Effect; Image Interpretation; Structural Similarity Index Measure; SSIM
• Other Study ID Numbers: MSOT_Lerneffekt

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: Yes