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Handheld Ultrasound at Remote Locations

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ClinicalTrials.gov Identifier: NCT03547076
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Levanger and Verdal Muncipality
Information provided by (Responsible Party):
Havard Dalen, Levanger Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: Focused ultrasound diagnostics Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: The Use of Handheld Ultrasound Utilizing Support by Experts or Automatic Analyses for Improved Diagnostics at Remote Locations
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Focused ultrasound diagnostics

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

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).





Primary Outcome Measures :
  1. Clinical influence of diagnostic ultrasound examinations supported by telemedicine [ Time Frame: Clinical influence will be tested on day 0 (time of study inclusion) ]
    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


Secondary Outcome Measures :
  1. Feasibility of handheld cardiac ultrasound performed by general practitioners [ Time Frame: Feasibility will be tested on day 0 (time of study inclusion) ]
    ReliabiFeasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the operator.


Other Outcome Measures:
  1. Feasibility of handheld cardiac ultrasound performed by general practitioners supported by automatic interpretation of left ventricular function. [ Time Frame: Feasibility will be tested on day 0 (time of study inclusion) ]
    Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the general practitioners and successfully automatically interpreted

  2. Feasibility of handheld cardiac ultrasound performed by general practitioners with expert support by telemedicine [ Time Frame: Feasibility will be tested on day 0 (time of study inclusion) ]
    Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the general practitioners and successfully interpreted by experts utilizing a near real-time telemedicine approach.

  3. Reliability of handheld cardiac ultrasound performed by general practitioners [ Time Frame: Reliability will be tested on day 0 (time of study inclusion) ]
    Reliability, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the operator.

  4. Reliability of handheld cardiac ultrasound performed by general practitioners supported by automatic interpretation of left ventricular function. [ Time Frame: Reliability will be tested on day 0 (time of study inclusion) ]
    Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation of left ventricular function by the algorithms included in the handheld ultrasound device compared to Reference imaging by specialists in cardiology

  5. Reliability of handheld cardiac ultrasound performed by general practitioners with expert support by telemedicine [ Time Frame: Reliability will be tested on day 0 (time of study inclusion) ]
    Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology

  6. Feasibility of handheld cardiac ultrasound performed by nurses supported by automatic interpretation of left ventricular function. [ Time Frame: Feasibility will be tested on day 0 (time of study inclusion) ]
    Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses and successfully automatically interpreted

  7. Feasibility of handheld cardiac ultrasound performed by nurses with expert support by telemedicine [ Time Frame: Feasibility will be tested on day 0 (time of study inclusion) ]
    Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses and successfully interpreted by experts utilizing a near real-time telemedicine approach.

  8. Reliability of handheld cardiac ultrasound performed by nurses supported by automatic interpretation of left ventricular function. [ Time Frame: Reliability will be tested on day 0 (time of study inclusion) ]
    Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation of left ventricular function by the algorithms included in the handheld ultrasound device compared to Reference imaging by specialists in cardiology

  9. Reliability of handheld cardiac ultrasound performed by nurses with expert support by telemedicine [ Time Frame: Reliability will be tested on day 0 (time of study inclusion) ]
    Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology

  10. Time use of handheld cardiac ultrasound performed by inexperienced users with expert support by telemedicine [ Time Frame: Time consumption will be tested on day 0 (time of study inclusion) ]
    Time used for the sum of recording of cardiac ultrasound examination, telemedicine transfer of recordings and telemedicine interpretation by experts.

  11. Quality of cardiac ultrasound performed by general practitioners [ Time Frame: Quality will be tested on day 0 (time of study inclusion) ]
    Evaluation of the quality of recordings of cardiac ultrasound obtained by the general practitioners as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist.

  12. Quality of cardiac ultrasound performed by nurses [ Time Frame: Quality will be tested on day 0 (time of study inclusion) ]
    Evaluation of the quality of recordings of cardiac ultrasound obtained by the nurses as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist.

  13. Evaluation of different methods for cardiac ultrasound user support [ Time Frame: Usability of methods of support will be tested on day 0 (time of study inclusion) ]
    User evaluation of the usability assessed by the system usability scale.

  14. Health care related cost of diagnostic handheld ultrasound algorithms in patients with suspected heart failure examinations supported by telemedicine [ Time Frame: Health care related cost will be tested on day 0 (time of study inclusion) ]
    Health care related cost will be evaluated by the costs related to the diagnostic algorithms in patients with suspected heart failure



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547076


Contacts
Contact: Håvard Dalen, MD, PhD 95871716 ext 0047 havard.dalen@ntnu.no
Contact: Ole Christian Mjølstad, MD, PhD 97034285 ext 0047 ole.c.mjolstad@ntnu.no

Locations
Norway
Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust Recruiting
Levanger, Norway, 7600
Contact: Havard Dalen, MD, PhD    74098206    havard.dalen@hnt.no   
Contact: Bjørn O Haugen, MD, PhD    +4773595000    bjornoh@gmail.com   
Principal Investigator: Håvard Dalen, MD, PhD         
Sponsors and Collaborators
Levanger Hospital
Norwegian University of Science and Technology
Levanger and Verdal Muncipality
Investigators
Study Chair: Havard Dalen, MD, PhD Norwegian University of Science and Tehnology

Responsible Party: Havard Dalen, Associate professor, Levanger Hospital
ClinicalTrials.gov Identifier: NCT03547076     History of Changes
Other Study ID Numbers: LE-2018_GP1
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD share will follow regulations from the institutions.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Havard Dalen, Levanger Hospital:
Pocket sized imaging device
Handheld ultrasound device
General practitioner
Nurse
Focused cardiac ultrasound
FoCUS
Telemedicine
Support

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases