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This validation study compares clinical palpation and ultrasonographic measurements of tissue compressibility using standardized phantom models. Operators with different levels of clinical and ultrasound experience perform repeated, blinded assessments across multiple sessions. The study evaluates accuracy, reliability, agreement between modalities, and learning effects over time, aiming to support standardized and more objective assessment of tissue compressibility in clinical practice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonographic Compression Measurment and Palpation of Standardized Phantom Models | Behavioral | Repeated ultrasonographic compression measurements and palpation of standardized phantom models |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy and reliability of palpation and ultrasonographic compression measurements | Intraoperator and interoperator accuracy and reliability of palpation and ultrasonographic compression measurements on two phantom models as intraclass correlation coefficient and linear mixed-effects model | Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of operator characteristics on the measurement accuracy and reliability. | Operator characteristics (age, gender, level of experience) will be introduced as fixed effects in a linear mixed-effects model with a random effect for participants to account for repeated measurements | Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with different years of clinical experience and levels of experience in ultrasound diagnostics (medical students, residents, and attendings) will be included. Age >= 18 years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern | Bern | 3010 | Switzerland |
The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
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The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
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| Assess the learning curve in palpation and ultrasound measurements | Changes in accuracy of both modalities using linear mixed-effects model with a random effect for participants to account for repeated measurements. To test possible confounding factors, they will be introduced as fixed effects. | Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks) |
| Correlate the compression measurements with palpatory assessment | Correlation of both modalities using linear mixed-effects model with a random effect for participants to account for repeated measurements. To test possible confounding factors, they will be introduced as fixed effects. | Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks) |
| ID | Term |
|---|---|
| D003128 | Coma |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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