- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541768
Training Medical Residents in the Use of the Venous Excess UltraSound (VExUS) Score for Bedside Volume Assessment.
Training Medical Residents in the Use of the Venous Excess UltraSound (VExUS) Score for Bedside Volume Assessment: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Accurate assessment of volume status is essential in managing acute heart failure but remains challenging in clinical practice. The VExUS score is a validated ultrasound-based tool integrating inferior vena cava diameter and Doppler assessment of hepatic, portal, and intrarenal veins.
This single-center randomized controlled trial compares two training modalities (in-person vs. remote) in medical residents with basic ultrasound skills. Participants will be randomized 1:1 to either training method and compared to a control group of expert physicians.
Primary outcomes include ultrasound image quality assessed using a standardized 100-point score. Secondary outcomes include time to acquisition, VExUS scoring accuracy, self-confidence, and acceptability of training methods.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline Rimensberger, MD
- Phone Number: 0041316322111
- Email: caroline.rimensberger@insel.ch
Study Contact Backup
- Name: Claudio Schneider, MD
- Phone Number: 0041316322111
- Email: claudio.schneider@insel.ch
Study Locations
-
-
-
Bern, Switzerland, 3011
- Recruiting
- Inselspital
-
Contact:
- General Internal Medicine
- Phone Number: 0041316322367
- Email: sekretariat.meas@insel.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical residents in general internal medicine
- Basic ultrasound skills (POCUS component 1 or ≥200 scans)
- Working at study site during study period
Exclusion Criteria:
- SGUM certification in abdominal ultrasound
- Advanced duplex ultrasound experience
- Prior vascular/duplex training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In-person Training
1-hour theoretical introduction 3-hour supervised practical ultrasound session Group-based hands-on training with expert coach
|
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.
|
|
Experimental: Remote Training
E-learning theoretical module 20 independently performed ultrasound exams Asynchronous expert feedback (phone/email)
|
Remote training consisting of an e-learning module followed by independently performed ultrasound examinations with asynchronous expert feedback (via phone or email).
|
|
Active Comparator: Control (Expert Physicians)
SGUM-certified physicians performing VExUS examinations
|
SGUM-certified physicians performing VExUS examinations as expert reference standard.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound Image Quality Score
Time Frame: From training until 6 months after completion of training
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for Image Acquisition and Interpretation
Time Frame: From training until 6 months after completion of training
|
Time required by participants to perform the ultrasound examination and interpret the images during VExUS assessment
|
From training until 6 months after completion of training
|
|
Change in self-confidence in performing VExUS assessment
Time Frame: From baseline (before training) to immediately after completion of training
|
Self-reported confidence measured using a Likert-scale questionnaire before and after training
|
From baseline (before training) to immediately after completion of training
|
|
Acceptability of the program (quantitative assessment)
Time Frame: Immediately after completion of training and during the outcome assessment period (within 2 months after training)
|
Acceptability of the program will be assessed using a structured survey with 5-point Likert scale items based on an implementation framework (e.g., Theoretical Domains Framework).
Results will be reported as mean scores or median values on a 5-point scale, where higher scores indicate greater acceptability.
|
Immediately after completion of training and during the outcome assessment period (within 2 months after training)
|
|
VEXUS score
Time Frame: From training until 6 months after completion of training
|
The Venous Excess Ultrasound Score (VExUS) is a semi-quantitative ultrasound-based score used to assess systemic venous congestion by combining inferior vena cava (IVC) diameter and Doppler flow patterns of abdominal veins, including hepatic, portal, and intrarenal veins.
The score ranges from 0 to 3, with 0 indicating no congestion, 1 indicating mild congestion, 2 indicating moderate congestion, and 3 indicating severe venous congestion.
Higher scores indicate greater venous congestion and worse clinical status.
|
From training until 6 months after completion of training
|
|
Acceptability of the program (qualitative assessment)
Time Frame: Immediately after completion of training and during the outcome assessment period (within 2 months after training)
|
Acceptability, including perceived barriers and facilitators to implementation, will be explored through semi-structured interviews.
Data will be analyzed using thematic analysis guided by an implementation framework.
|
Immediately after completion of training and during the outcome assessment period (within 2 months after training)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEXUS Teaching
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congestion
-
Third Wave TherapeuticsCompleted
-
McNeil ABCompletedNasal CongestionRussian Federation
-
GlaxoSmithKlineCompletedCongestion, NasalUnited States
-
GlaxoSmithKlineCompletedNasal CongestionUnited Kingdom
-
University of ChicagoSanofiCompletedMucosal CongestionUnited States
-
Johnson & Johnson Consumer and Personal Products...Completed
-
GlaxoSmithKlineCompletedCongestion, NasalUnited States
-
Catharina Ziekenhuis EindhovenCompletedPulmonary CongestionNetherlands
-
Omega PharmaCompleted
-
University Hospital, BrestRecruitingCongestion, VenousFrance
Clinical Trials on In-person VExUS Training Program
-
University of DelawareUniversity of Illinois at ChicagoCompleted
-
New York UniversityNational Cancer Institute (NCI); University of California, Los Angeles; Partners...RecruitingCervical Cancer PreventionMalawi
-
Stanford UniversityJimma University; Laerdal FoundationCompletedNeonatal Death | Birth AsphyxiaEthiopia
-
NYU Langone HealthCompletedMigraineUnited States
-
University of California, San FranciscoCompletedChronic Disease | Health Literacy | Electronic Health Records
-
GO fit Lab- IngesportRecruiting
-
VA Office of Research and DevelopmentMedical University of South Carolina; National Center for PTSDRecruiting
-
University of PittsburghCompleted
-
Pro Consumer Safety - Public Health Behavior SolutionsUniversity of Southern CaliforniaCompletedMotor Vehicle InjuryUnited States