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

NCT ID: NCT05773547

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-17

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Multispectral Optoacoustic Tomography Learning Curve Image Interpretation, Computer-Assisted Structural Similarity Index Measure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Professional

Two investigators who have performed over 200 MSOT measurements.

MSOT measurements

Intervention Type DEVICE

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.

MSOT measurements

Intervention Type DEVICE

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.

MSOT measurements

Intervention Type DEVICE

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.

MSOT measurements

Intervention Type DEVICE

Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses

Interventions

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MSOT measurements

Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Erlangen

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Rother

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrich Rother, PD Dr. med.

Role: CONTACT

+4991318542028

Facility Contacts

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Ulrich Rother, Dr. med.

Role: primary

+4991318542028

Werner Lang, Prof. Dr. med.

Role: backup

+4991318532968

Other Identifiers

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MSOT_Lerneffekt

Identifier Type: -

Identifier Source: org_study_id

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