Palpatory and Ultrasonographic Assessment of Tissue Compressibility: Validation and Learning Effects in Phantom Models

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Exanimation; Diagnostic Ultrasound; Palpation
• Intervention / Treatment: Behavioral: Ultrasonographic Compression Measurment and Palpation of Standardized Phantom Models

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Medical professionals and medical students

Exclusion Criteria:

• Age <18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diagnostic Ultrasound; Palpation; Exanimation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coma
• Other Study ID Numbers: Req-2025-01655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
• IPD Sharing Access Criteria: The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No