Screening of Patients Admitted to a Local Hospital With Pocket-sized Ultrasound

Completed

• Conditions: Kidney Disease; Heart Disease; Liver Disease; Dyspnea; Aortic Disease
• Interventions: Other: Ultrasound examination

• Registration Number: NCT01081210
• Lead Sponsor: Helse Nord-Trøndelag HF

Brief Summary

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 both on behalf of the patients well-being, and for hospital logistic reasons.

1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in an department of internal medicine.

Method: All patients admitted (in certain preset periods) to Department of medicine will be screened with pocket sized US by expert user. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department.

2. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in a department of cardiology.

Method: All patients admitted (in certain preset periods) to Department of cardiology will be screened with pocket sized US for heart disease, pericardial and pleural effusion. Examinations by expert users. Specific findings could be myocardial dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia, valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography in all.

3. As in 1), but examination by non-expert users compared to expert users.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Study Start: 2010-03
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients admitted to Dep. of Medicine at Levanger Hospital

Exclusion Criteria

• Not able to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound screening	Ultrasound examination	Patients admitted to Department of medicine at local hospital. Randomized inclusion, informed consent obtained.

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity and specificity	After 3-6 months	Diagnostic accuracy and clinical usefulness of ultrasound screening as add on examination. Change in working diagnosis after ultrasound examination will be tested, and gold standards (echocardiography and examinations at Department of radiology) will be used for testing of sensitivity and specificity.

Secondary Outcome Measures

Name	Time	Method
Non-experts	After 3-6 months	Validation of results from ultrasound examination made by non-experts compared to expert users.

Trial Locations

Locations (2)

Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust; 🇳🇴 Levanger, Norway

Levanger Hospital, Department of Medicine; 🇳🇴 Levanger, Norway