Fluid Status of Outpatients With Dyspnea
Completed
Conditions studied: Dyspnea,, Acute Heart Failure Syndrome, Pulmonary Congestion
In brief
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.
Key facts
- Study ID
- NCT02111525
- Run by
- Intersection Medical, Inc.
- People needed
- 156
- Starts
- 2014-06-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2015-10-14
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Shortness of breath as the most prominent presenting symptom
- Age greater ≥ 45
- Willingness, ability, and commitment to participate in the study
You may not qualify if…
- 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.)
Where it is running
- Wayne State University Hospital — Detroit, Michigan, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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