Fluid Status of Outpatients With Dyspnea

NCT02111525 | Completed

• 1 other identifier: CP-000030
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 2

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.

Conditions

Dyspnea,; Acute Heart Failure Syndrome; Pulmonary Congestion

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.)

Sponsors & Collaborators

• Intersection Medical, Inc.: lead

Study Sites (2)

Wayne State University Hospital

Detroit, Michigan, 48201, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 11, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (2)