Ultrasound by Nurses in Heart Failure Patients

NCT ID: NCT01794715

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Heart Failure

Keywords

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Heart failure Nurse led Outpatient clinic Echocardiography Pocket-size Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound performed by nurses

Examinations including ultrasound examinations

Group Type EXPERIMENTAL

Ultrasound examination by nurses

Intervention Type PROCEDURE

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

Ultrasound not performed

Examinations not including ultrasound examinations, otherwise active

Group Type ACTIVE_COMPARATOR

Ultrasound examination by nurses

Intervention Type PROCEDURE

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

Interventions

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Ultrasound examination by nurses

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

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not able or not willing to concent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Nord-Trøndelag HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Levanger, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 28320791 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26438785 (View on PubMed)

Other Identifiers

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Spl hjertesvikt

Identifier Type: OTHER

Identifier Source: secondary_id

LH-2013-1

Identifier Type: -

Identifier Source: org_study_id