Fluid Status of Outpatients With Dyspnea (FLOOD)
Verified June 2014 by Intersection Medical, Inc.
Information provided by (Responsible Party):
Intersection Medical, Inc.
First received: April 8, 2014
Last updated: June 25, 2014
Last verified: June 2014
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.
Acute Heart Failure Syndrome
||Observational Model: Cohort
Time Perspective: Prospective
||Fluid Status of Outpatients With Dyspnea
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||45 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Shortness of breath as the most prominent presenting symptom
- Age greater ≥ 45
- Willingness, ability, and commitment to participate in the study
- 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.)
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
|Wayne State University Hospital
|Detroit, Michigan, United States, 48201 |
|Contact: Phillip Levy, MD firstname.lastname@example.org |
|Principal Investigator: Phillip Levy, MD |
|Nashville, Tennessee, United States, 37235 |
|Contact: Sean P Collins, MD, MSc, FACC, FAHA sean.collins@Vanderbilt.Edu |
|Principal Investigator: Sean P Collins, MD |
Intersection Medical, Inc.
No publications provided
||Intersection Medical, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 8, 2014
||June 25, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms