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CompletedNCT02111525FLOODUpdated Oct 14, 2015

Fluid Status of Outpatients With Dyspnea

An observational study in Dyspnea,, Acute Heart Failure Syndrome and Pulmonary Congestion, sponsored by Intersection Medical, Inc.. Completed at 2 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Intersection Medical, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
156
Ages
45 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspnea,
  • Acute Heart Failure Syndrome
  • Pulmonary Congestion

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03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 156 is above the median of 122 across 204 observational studies indexed under Dyspnea.

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Lead sponsor

Intersection Medical, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
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.

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

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.)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
156 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: Up to 1 year

07

Study locations

2 sites
  • Wayne State University Hospital
    Detroit, Michigan 48201, United States
  • Vanderbilt University
    Nashville, Tennessee 37235, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02111525
Lead sponsor
Intersection Medical, Inc.
Responsible party
Sponsor
First posted
Apr 11, 2014
Start date
Jun 2014
Primary completion
Sep 2015
Completion
Oct 2015
Last update
Oct 14, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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