Handheld Ultrasound at Remote Locations

NCT03547076 | Completed DMC

• 1 other identifier: LE-2018_GP1
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure causes a large patient and financial burden on the health care system. Pocket ultrasound imaging devices are utilized to improve time to correct diagnosis. Telemedicine is used in a variety of medical professions today. A combination of focused handheld ultrasound imaging performed by general practitioners and dedicated nurses in a heart failure population, utilizing telemedicine for support, has not yet been studied. The aim of the study is to evaluate the feasibility, reliability and clinical influence of implementing handheld focused cardiac ultrasound by general practitioners and nurses for diagnostics and health-related expenditure in outpatients referred with suspected heart failure.

Conditions

Heart Failure

Keywords

Pocket sized imaging device; Handheld ultrasound device; General practitioner; Nurse; Focused cardiac ultrasound; FoCUS; Telemedicine; Support

Outcome Measures

Primary Outcomes (1)

• Clinical influence of diagnostic ultrasound examinations supported by telemedicine

  Clinical influence will be evaluated by the proportion of patients correct evaluated to have or not to have heart failure by the use of handheld ultrasound

  Clinical influence will be tested on day 0 (time of study inclusion)

Secondary Outcomes (1)

• Feasibility of handheld cardiac ultrasound performed by general practitioners

  Feasibility will be tested on day 0 (time of study inclusion)

Other Outcomes (14)

• Feasibility of handheld cardiac ultrasound performed by general practitioners supported by automatic interpretation of left ventricular function.

  Feasibility will be tested on day 0 (time of study inclusion)

• Feasibility of handheld cardiac ultrasound performed by general practitioners with expert support by telemedicine

  Feasibility will be tested on day 0 (time of study inclusion)

• Reliability of handheld cardiac ultrasound performed by general practitioners

  Reliability will be tested on day 0 (time of study inclusion)

Study Arms (1)

Focused ultrasound diagnostics

EXPERIMENTAL

Intervention: Focused ultrasound Diagnostics All participants will first be examined twice with handheld ultrasound, With separate examinations performed by general practioners and nurses (random order). Both will utilize automatic analyses of left ventricular function and telemedicine support for best possible diagnosis of heart failure. Subsequently, reference imaging and diagnostics will be performed by experts (cardiologists). Handheld ultrasound examinations will be compared to Reference.

Diagnostic Test: Focused ultrasound diagnostics

Interventions

Focused ultrasound diagnostics DIAGNOSTIC_TEST

Patients first be examined by nurses using a pocket-sized imaging device. Secondly, by a General Practitioner using the pocket-sized imaging device. Thirdly, reference echocardiography will be performed by cardiologist using a high-end echocardiographic scanner. Only tools (ultrasound equipment and dedicated software) approved for clinical practice will be used. The focused ultrasound examination includes three standard apical views (4-chamber, 2-chamber and long axis) with and without color Doppler, in addition to recordings from both pleural cavities and the inferior vena cava. The reference imaging includes the same recordings, but in addition all other chambers and valves are assessed (grey scale, color Doppler, pulsed wave and continuous wave Doppler and tissue Doppler).

Focused ultrasound diagnostics

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the outpatient clinic at Levanger Hospital for echocardiography due to suspicion of heart failure, which have consented to participate in the study.
• N-terminal pro brain natriuretic peptide (NT-proBNP) ≥125 ng/L or brain natriuretic peptide ≥35 ng/L

You may not qualify if:

• The patient is not able to consent.
• The patient has know heart failure
• Known result of any of the following cardiac imaging tests (echocardiography, cardiac magnet resonance imaging (MRI), cardiac (not coronary) computed tomography (CT).

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator
• Levanger and Verdal Muncipality: collaborator

Study Sites (1)

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

Levanger, 7600, Norway

Location

Related Publications (1)

• Hjorth-Hansen AK, Magelssen MI, Andersen GN, Graven T, Kleinau JO, Landstad B, Lovstakken L, Skjetne K, Mjolstad OC, Dalen H. Real-time automatic quantification of left ventricular function by hand-held ultrasound devices in patients with suspected heart failure: a feasibility study of a diagnostic test with data from general practitioners, nurses and cardiologists. BMJ Open. 2022 Oct 13;12(10):e063793. doi: 10.1136/bmjopen-2022-063793.

  PMID: 36229153 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Havard Dalen, MD, PhD

  Norwegian University of Science and Tehnology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All study personnel will be masked for findings by other study personnel. Patients will first be examined by nurses or GP in a random order, then subsequently, reference examination will be performed by cardiologist experienced in heart failure diagnostics and echocardiography.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The focused Pocket ultrasound examination and evaluation will be performed by a general practitioner. A similar focused ultrasound examination will be performed by a nurse without evaluation by the nurse. The complete echocardiographic examination by a cardiologist, using a state of the art ultrasound machine is considered the gold standard method.

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: June 6, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

NO (1)