Fluid Status of Outpatients With Dyspnea

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02111525

Acronym

FLOOD

Enrollment

156

Registered

2014-04-11

Start date

2014-06-30

Completion date

2015-10-31

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure Syndrome, Dyspnea,, Pulmonary Congestion

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
Lung Fluid Status	Up to 1 year	The IMED 4 is a new device designed to measure the lung fluid status by assessing how wet or dry the lungs are

Countries

United States

Outcome results