NCT07541768

Brief Summary

This randomized controlled trial evaluates the effectiveness of two training approaches (in-person versus remote) for teaching medical residents to apply the Venous Excess Ultrasound (VExUS) score for bedside volume assessment in patients with acute heart failure. Resident performance will be compared to that of expert physicians certified in abdominal and duplex sonography.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 20, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

March 31, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

VexusVenous Excess UltrasoundPoint-of-Care UltrasoundPOCUSUltrasound TrainingMedical EducationVolume AssessmentVenous CongestionDuplex UltrasoundBedside Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Ultrasound Image Quality Score

    The primary outcome will be a quality score, adapted from a quality score used in a previous randomized controlled trial which investigated a simulator-based training program for transoesophageal echocardiography.11 The quality score will include items commonly used for assessment of ultrasound quality: angle and depth, overall clarity, visualization of the anatomical structures, focus, doppler gain, scale and baseline resulting in a maximum achievable quality score of 100 points. If multiple images of the predefined views are captured, each image will be rated, and the best rating will be kept to calculate the final score. If a view is missing, 0 point will be awarded for that view. All ultrasound images will be independently assessed by experts for abdominal sonography and use Doppler sonography in their daily clinical practice and are blinded to the role (resident vs. SGUM-certified physician) and training (in-person vs. remote) program of the participants.

    From training until 6 months after completion of training

Secondary Outcomes (5)

  • Time for Image Acquisition and Interpretation

    From training until 6 months after completion of training

  • Change in self-confidence in performing VExUS assessment

    From baseline (before training) to immediately after completion of training

  • Acceptability of the program (quantitative assessment)

    Immediately after completion of training and during the outcome assessment period (within 2 months after training)

  • VEXUS score

    From training until 6 months after completion of training

  • Acceptability of the program (qualitative assessment)

    Immediately after completion of training and during the outcome assessment period (within 2 months after training)

Study Arms (3)

In-person Training

EXPERIMENTAL

1-hour theoretical introduction 3-hour supervised practical ultrasound session Group-based hands-on training with expert coach

Behavioral: In-person VExUS Training Program

Remote Training

EXPERIMENTAL

E-learning theoretical module 20 independently performed ultrasound exams Asynchronous expert feedback (phone/email)

Behavioral: Remote VExUS Training Program

Control (Expert Physicians)

ACTIVE COMPARATOR

SGUM-certified physicians performing VExUS examinations

Other: No intervention

Interventions

In-person training consisting of a 1-hour theoretical introduction followed by a 3-hour supervised hands-on ultrasound training session focusing on acquisition and interpretation of the VExUS score.

In-person Training

Remote training consisting of an e-learning module followed by independently performed ultrasound examinations with asynchronous expert feedback (via phone or email).

Remote Training

SGUM-certified physicians performing VExUS examinations as expert reference standard.

Control (Expert Physicians)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical residents in general internal medicine
  • Basic ultrasound skills (POCUS component 1 or ≥200 scans)
  • Working at study site during study period

You may not qualify if:

  • SGUM certification in abdominal ultrasound
  • Advanced duplex ultrasound experience
  • Prior vascular/duplex training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital

Bern, 3011, Switzerland

RECRUITING

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Caroline Rimensberger, MD

CONTACT

Claudio Schneider, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 21, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations