Influence of Routinely Adding Ultrasound Screening in Medical Department

Study Overview
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Brief Summary
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Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic tool in these diagnosis, and on early diagnosis is crucial with respect to the patients well-being and inpatients workflow. 1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in an medical department with respect to inpatients workflow and diagnostics. Method: Patients admitted (in certain preset periods) to Department of medicine will be randomized to routinely adding an ultrasound examination with pocket-size device by residents on call. Time to definitive diagnosis, time to definitive treatment and time to discard will be recorded. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department.

Official Title
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Influence on Diagnostics and Inpatient Workflow of Routinely Adding Ultrasound Screening by Pocket-size Ultrasound in a Medical Department

Conditions
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Dyspnea, Heart Disease, Aortic Disease, Kidney Disease, Liver Disease

Intervention / Treatment
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* Procedure: Pocket-size ultrasonography
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to Dep. of Medicine at Levanger Hospital Exclusion Criteria: Not able to give informed consent

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care diagnostics. No routinely ultrasound examination | Other: Usual care<br>* No intervention, except for usual care (goal-directed diagnostics)<br>|
| Experimental: Routinely ulasonography<br>Patients will routinely be examined with ultrasound at admittance in addition to usual care diagnostics | Procedure: Pocket-size ultrasonography<br>* Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to definitive diagnosis | Time from admittance to definitive diagnosis | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reproducibility | Pocket-sized ultrasound recordings by residents will be validated against reference methods (echocardiography and radiologic examinations by sepcialists)to assess sensitivity, specificity, positive and negative predictive values of pocket-size ultrasound. | 3 months | 
| Diagnostic outcome of additional ultrasound examination according to educational level of the performer | Study the diagnostic outcome of ultrasound screening related to the educational level and skills of the user | 3 months | 
| Time to definitive treatment | Time from admittance to definitive treatment | 3 months | 
| Time to discharge | Time from patients admittance to discharge from hospital | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, Heart failure, Ultrasonography, pocket-size device, Aorta, Education