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

NCT07386782 | Active Not Recruiting

• 1 other identifier: Req-2025-01655
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exanimation; Diagnostic Ultrasound; Palpation

Keywords

Exanimation; Diagnostic Ultrasound; Palpation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of operator characteristics on the measurement accuracy and reliability.

  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

  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

  Over 3 sessions, seperated by at least 1 day and at most 1 week (study duration: 3 days to 2 weeks)

Interventions

Ultrasonographic Compression Measurment and Palpation of Standardized Phantom Models BEHAVIORAL

Repeated ultrasonographic compression measurements and palpation of standardized phantom models

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Medical professionals and medical students

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 4, 2026
• Study Start: January 31, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: The data supporting this study's findings are available upon request from Samuel Tschopp, the corresponding author.

Locations

CH (1)