Ultrasound by Nurses in Heart Failure Patients

November 5, 2021 updated by: Helse Nord-Trøndelag HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Levanger, Norway, 7600
        • Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able or not willing to concent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound performed by nurses
Examinations including ultrasound examinations
Procedure: Ultrasound examination by nurses
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
Other Names:
  • Ultrasound
Active Comparator: Ultrasound not performed
Examinations not including ultrasound examinations, otherwise active
Procedure: Ultrasound examination by nurses
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
Other Names:
  • Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment effect
Time Frame: 0 and 30 days and 6 months
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
Time Frame: 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).
0 and 30 days and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
proBNP vs ultrasound
Time Frame: 0 and 30 days
Study of which variable that best predicts the clinical treatment of the population
0 and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 16, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LH-2013-1
  • Spl hjertesvikt (Other Identifier: Levanger Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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