Fluid Status of Outpatients With Dyspnea

NCT ID: NCT02111525

Last Updated: 2015-10-14

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

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath.

Detailed Description

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Conditions

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Dyspnea, Acute Heart Failure Syndrome Pulmonary Congestion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Shortness of breath as the most prominent presenting symptom
* Age greater ≥ 45
* Willingness, ability, and commitment to participate in the study

Exclusion Criteria

* Patients with any active implantable medical device
* Patients who are pregnant or lactating
* Patients who have tattoos and or non-intact skin directly under the electrode position
* Patients who have had past allergic reactions to medical grade adhesives
* Patients that are dialysis dependent
* Patients who have had a lung lobectomy
* Patients in whom the shortness of breath presentation is due to obvious non HF cause such as acute chest trauma
* Patients who have received nitrates (sub-lingual, topical or IV), diuretics or vasopressors ≥ 1 hour prior to IMED-4 Recording
* Patients who decline to have their backs photographed with the IMED-4 device in position
* Patients who are receiving invasive or non-invasive positive airway pressure (PAP) ventilation prior to or following presentation to the ED (Self presentation or admission via EMS).
* Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectancy, etc.)
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intersection Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wayne State University Hospital

Detroit, Michigan, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CP-000030

Identifier Type: -

Identifier Source: org_study_id

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