Ultrasound by Nurses in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794715
• Other study ID #: LH-2013-1
• Secondary ID: Spl hjertesvikt
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2021
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not able or not willing to concent

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Ultrasound examination by nurses
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.

Locations

Country	Name	City	State
Norway	Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust	Levanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	proBNP vs ultrasound	Study of which variable that best predicts the clinical treatment of the population	0 and 30 days
Primary	Treatment effect	Change in treatment after routinely performed ultrasound vs no ultrasound performed.	0 and 30 days and 6 months
Secondary	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