Fluid Status of Outpatients With Dyspnea (FLOOD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Intersection Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Intersection Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02111525
First received: April 8, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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
Dyspnea,
Acute Heart Failure Syndrome
Pulmonary Congestion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluid Status of Outpatients With Dyspnea

Resource links provided by NLM:


Further study details as provided by Intersection Medical, Inc.:

Primary Outcome Measures:
  • Lung Fluid Status [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The IMED 4 is a new device designed to measure the lung fluid status by assessing how wet or dry the lungs are


Estimated Enrollment: 500
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111525

Locations
United States, Michigan
Wayne State University Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Phillip Levy, MD       plevy@med.wayne.edu   
Principal Investigator: Phillip Levy, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37235
Contact: Sean P Collins, MD, MSc, FACC, FAHA       sean.collins@Vanderbilt.Edu   
Principal Investigator: Sean P Collins, MD         
Sponsors and Collaborators
Intersection Medical, Inc.
  More Information

No publications provided

Responsible Party: Intersection Medical, Inc.
ClinicalTrials.gov Identifier: NCT02111525     History of Changes
Other Study ID Numbers: CP-000030
Study First Received: April 8, 2014
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014