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OpenTrials
Completed

NCT Number: NCT02111525

Fluid Status of Outpatients With Dyspnea

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wayne State University Hospital, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Intersection Medical, Inc.

Industry

Registry information

Acronym: FLOOD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2014
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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