Fluid Status of Outpatients With Dyspnea (FLOOD)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Congestion; Dyspnea,; Acute Heart Failure Syndrome

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who present with shortness of breath to an emergency department or urgent care facility are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Intersection Medical, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (ESTIMATE): April 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: CP-000030