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Evaluation of the Ergonomics and Usability of a Point-of-Care Handheld Ultrasound System Using Mixed Reality (MR) Glasses

Evaluation of the Ergonomics and Usability of a Point-of-Care Handheld Ultrasound System Using Mixed Reality (MR) Glasses - Easy-MR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039752
Enrollment
100
Registered
2026-03-27
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generally speaking, these patients are individuals who are in the intensive care unit (ICU) or intermediate care unit (IMC) due to various medical conditions.

Interventions

Group 1: The study is designed as a prospective, exploratory observational study. A preliminary study has already been conducted in a laboratory setting (simulation phase) using a medical dummy. Afte

Sponsors

Helios Dr. Horst Schmidt Klinik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Medical indication for ultrasound-guided vascular puncture, The patient's capacity to give informed consent

Exclusion criteria

Exclusion criteria: Under 18 Refusal to participate in an interview-based survey Lack of written consent

Design outcomes

Primary

MeasureTime frame
The primary endpoint is usability, measured using a standardized questionnaire based on the System Usability Scale (SUS). The quantitative analysis focuses in particular on the dimensions of usability, ergonomics, and the comprehensibility of the imaging.

Secondary

MeasureTime frame
The secondary endpoints relate to the clinical application of ultrasound-guided vascular cannulation under VR conditions and include: Duration of the procedure (defined as the duration of the sterile phase) Duration of the puncture (defined as the time from the first puncture attempt to successful catheter insertion) Number of puncture attempts (including failed punctures) Number of guidewire placements (as a measure of technical feasibility) Complications, in particular: Hematoma formation (assessment on the following day, taking anticoagulation into account) Catheter-associated infections Termination of the puncture for other reasons Suspected nerve injury (sensory deficits on the following day)

Countries

Germany

Contacts

Public ContactTobias Bexten

Helios Dr. Horst Schmidt Kliniken

tobias.bexten@helios-gesundheit.de+49 611 430

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026