Ultrasound by Nurses in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Ultrasound examination by nurses

• Registration Number: NCT01794715
• Lead Sponsor: Helse Nord-Trøndelag HF

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-16
• Study First Posted: 2013-02-20
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

Exclusion Criteria

• Not able or not willing to concent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ultrasound not performed	Ultrasound examination by nurses	Examinations not including ultrasound examinations, otherwise active
Ultrasound performed by nurses	Ultrasound examination by nurses	Examinations including ultrasound examinations

Primary Outcome Measures

Name	Time	Method
Treatment effect	0 and 30 days and 6 months	Change in treatment after routinely performed ultrasound vs no ultrasound performed.

Secondary Outcome Measures

Name	Time	Method
Quality of nurse performed ultrasound	0 and 30 days and 6 months	Validation of nurse driven ultrasound. Measures of detection of volume state and specific ultrasonographic measurements compared to reference method (cardiologist performer ultrasound).

Trial Locations

Locations (1)

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