KYMA Device: External Measure of Thoracic Fluid and Vital Signs
NCT ID: NCT02369042
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2014-10-31
2017-04-19
Brief Summary
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Detailed Description
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The goals of the study are:
1. Follow thoracic fluid and vital signs in acute, hospitalized heart failure(HF) patients with evidence of volume overload to evaluate this combined parameter in relation to decongestion (time to clear lung auscultation or clearing of congestion on chest x-ray or decrease in BNP by 50%), clinical symptoms, physical exam, and biomarker results.
2. Evaluate the relationship between lung decongestion as externally measured and hemodynamic parameters as measured by pulmonary artery catheter in a subset of patients
3. Correlate changes in thoracic fluid content and vital signs with clinical changes in the outpatient setting for 60 days post-discharge.
4. Evaluate the feasibility of implementing a physician-directed, patient- managed model of diuretic and vasodilator adjustment.
Patients will be approached for enrollment within 24 hours of presentation to the hospital. The Kyma device will be applied to the patient. Data will be automatically collected by the device: TFC will be measured every 30 minutes and vital signs will be measured several times an hour.
Information collected at baseline by the study coordinators will include medications, lab work (CBC, Chemistry, BNP), ejection fraction(EF), weight, vital signs, and lung auscultation for both Cohorts.
Cohorts I and II may be enrolled concurrently. For patients enrolled in Cohort I, PA readings will be recorded at baseline and 3 times daily until the pulmonary artery(PA) catheter is removed.
While hospitalized, all patients will have daily weights, intake/output, Physical Exams(edema, jugular venous distention(JVP), lung exam) and vital signs will be recorded twice daily. Lab results will be recorded as well as any changes in medication.
After hospital discharge, the patients will wear the Kyma device for an additional 60 days. Patients will be contacted by telephone at 10 days, 30 days, and 60 days post-discharge for weight measurements, medication changes, and assessment of any Office Visits, or ER/Hospitalizations for SOB.
The Minnesota Living with Heart Failure Questionnaire will be administered at hospital discharge and 30 and 60 days post-discharge.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
TRIPLE
Study Groups
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Cohort I
Patients admitted with the primary diagnosis of HF and are currently being assessed with clinically indicated hemodynamic monitoring.The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected through hemodynamic monitoring. The device will be worn for 60 days post hospital discharge.
Kyma Device u-Cor System
The Kyma uCor system externally measures thoracic fluid content, heart rate, respiratory rate, posture and movement. The system includes a flat antenna that is attached to the patient's torso with a bandage-like sticker. The antenna transmits radio waves and receives their reflections from the body for several seconds every few hours throughout the day.The data is recorded and collected then compared to traditional clinical parameters.
Cohort II
Patients admitted with the primary diagnosis of HF and are being assessed with or without hemodynamic monitoring. The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected while the patient is hospitalized. The device will be worn for 60 days post hospital discharge.
Kyma Device u-Cor System
The Kyma uCor system externally measures thoracic fluid content, heart rate, respiratory rate, posture and movement. The system includes a flat antenna that is attached to the patient's torso with a bandage-like sticker. The antenna transmits radio waves and receives their reflections from the body for several seconds every few hours throughout the day.The data is recorded and collected then compared to traditional clinical parameters.
Interventions
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Kyma Device u-Cor System
The Kyma uCor system externally measures thoracic fluid content, heart rate, respiratory rate, posture and movement. The system includes a flat antenna that is attached to the patient's torso with a bandage-like sticker. The antenna transmits radio waves and receives their reflections from the body for several seconds every few hours throughout the day.The data is recorded and collected then compared to traditional clinical parameters.
Eligibility Criteria
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Inclusion Criteria
1. Men or women over 18 years of age
2. Admitted for primary diagnosis of HF
3. Already assigned for indwelling PA catheter monitoring
4. BNP \> 400
5. Two of the following: edema, JVP\>7cm, rales
6. Currently being assessed with clinically indicated hemodynamic monitoring
Cohort II
1. Men or women over 18 years of age
2. Admitted with the primary diagnosis of HF
3. BNP \> 400
4. Two of the following: edema, JVP\> 7cm, rales
5. Patients with or without hemodynamic monitoring in use
Exclusion Criteria
1. Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive
2. Pregnant women
18 Years
ALL
No
Sponsors
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The Christ Hospital
OTHER
Responsible Party
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Dr. Eugene Chung
MD
Principal Investigators
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Eugene Chung, MD
Role: PRINCIPAL_INVESTIGATOR
The Lindner Research Center at The Christ Hospital
Locations
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The Lindner Research Center at The Christ Hospitak
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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ChristH
Identifier Type: -
Identifier Source: org_study_id
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