Clinical trial NCT01794715: Ultrasound by Nurses in Heart Failure Patients
Official title: Is Routine Ultrasound Examination Performed by Nurses Useful in Heart Failure Patients at a Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Nurse led
Outpatient clinic
Echocardiography
Pocket-size
Ultrasound
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients referred to the outpatient heart failure clinic at the local hospital

Exclusion Criteria:

* Not able or not willing to concent

Primary outcomes:
measure: Treatment effect
timeFrame: 0 and 30 days and 6 months
Secondary outcomes:
measure: Quality of nurse performed ultrasound
timeFrame: 0 and 30 days and 6 months
Other outcomes:
measure: proBNP vs ultrasound
timeFrame: 0 and 30 days
Locations:
city: Levanger
country: Norway
facility: Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Study officials:
References:
citation: Gundersen GH, Norekval TM, Graven T, Haug HH, Skjetne K, Kleinau JO, Gustad LT, Dalen H. Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study. BMJ Open. 2017 Mar 20;7(3):e013734. doi: 10.1136/bmjopen-2016-013734.
citation: Gundersen GH, Norekval TM, Haug HH, Skjetne K, Kleinau JO, Graven T, Dalen H. Adding point of care ultrasound to assess volume status in heart failure patients in a nurse-led outpatient clinic. A randomised study. Heart. 2016 Jan;102(1):29-34. doi: 10.1136/heartjnl-2015-307798. Epub 2015 Oct 5.