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OpenTrials
Completed

NCT Number: NCT01794715

Ultrasound by Nurses in Heart Failure Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust

Levanger, 7600, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not able or not willing to concent

Treatment and study plan

Ultrasound examination by nurses

Procedure

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

Other names: Ultrasound

Primary outcomes

  1. Treatment effect

    Time frame: 0 and 30 days and 6 months

    Change in treatment after routinely performed ultrasound vs no ultrasound performed.

Secondary outcomes

  1. 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).

Other outcomes

  1. proBNP vs ultrasound

    Time frame: 0 and 30 days

    Study of which variable that best predicts the clinical treatment of the population

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2013
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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