Ultrasound by Nurses in Heart Failure Patients

Study Overview
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Brief Summary
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Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.

Detailed Description
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Patient inclusion: Outpatient heart failure clinic. Patients are eligible for inclusion if the are referred with heart failure and concent to participate in the study. No other exclusion criteria other than no willing/able to give their concent. Study population: Approximately 80 patients Intervention: All participants will undergo careful medical history, physical examination and blood tests led by nurses. All patients will be examined twice (by two nurses), one will routinely add ultrasound examination of the pleural space and the inferior vena cava to assess volume state, the other nurse will not perform ultrasound examination. Full cross-over design were nurses do ultrasound examinations at a random matter. Patients will then be examined by echocardiography by experience cardiologist's echocardiographers. Outcome measures:Change in therapy after routinely performed ultrasound examinations vs controls, detection of volume state when performing ultrasound examinations compared to controls with cardiologist's echocardiographic examination as a gold standard. Descriptive data of patients before, under and after examinations.

Official Title
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Is Routine Ultrasound Examination Performed by Nurses Useful in Heart Failure Patients at a Outpatient Clinic

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Ultrasound examination by nurses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred to the outpatient heart failure clinic at the local hospital Exclusion Criteria: Not able or not willing to concent
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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound performed by nurses<br>Examinations including ultrasound examinations | Procedure: Ultrasound examination by nurses<br>* Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.<br>* Other names: Ultrasound;|
| Active Comparator: Ultrasound not performed<br>Examinations not including ultrasound examinations, otherwise active | Procedure: Ultrasound examination by nurses<br>* Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.<br>* Other names: Ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effect | Change in treatment after routinely performed ultrasound vs no ultrasound performed. | 0 and 30 days and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of nurse performed ultrasound | Validation of nurse driven ultrasound. Measures of detection of volume state and specific ultrasonographic measurements compared to reference method (cardiologist performer ultrasound). | 0 and 30 days and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Nurse led, Outpatient clinic, Echocardiography, Pocket-size, Ultrasound