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Fluid Status of Outpatients With Dyspnea (FLOOD)

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ClinicalTrials.gov Identifier: NCT02111525
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Dyspnea, Acute Heart Failure Syndrome Pulmonary Congestion

Study Design

Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluid Status of Outpatients With Dyspnea
Study Start Date : June 2014
Primary Completion Date : September 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Lung Fluid Status [ Time Frame: 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111525


Locations
United States, Michigan
Wayne State University Hospital
Detroit, Michigan, United States, 48201
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Intersection Medical, Inc.
More Information

Responsible Party: Intersection Medical, Inc.
ClinicalTrials.gov Identifier: NCT02111525     History of Changes
Other Study ID Numbers: CP-000030
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Failure
Dyspnea
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms