Fluid Status of Outpatients With Dyspnea

Pulmonary Congestion Clinical Trial

— FLOOD  

Official title:

Fluid Status of Outpatients With Dyspnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111525
• Other study ID #: CP-000030
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: October 13, 2015
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Intersection Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Heart Failure Syndrome
• Dyspnea
• Dyspnea,
• Pulmonary Congestion

Locations

Country	Name	City	State
United States	Wayne State University Hospital	Detroit	Michigan
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Intersection Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No