Fluid Status of Outpatients With Dyspnea (FLOOD)

Intersection Medical

Status: Completed

Conditions: Acute Heart Failure Syndrome; Dyspnea,; Pulmonary Congestion

Study type: Observational

Funder types: Industry

Identifiers

NCT02111525

CP-000030

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.)