KYMA Device: External Measure of Thoracic Fluid and Vital Signs

NCT02369042 | Completed DMC

• 1 other identifier: ChristH
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies while tracking clinical changes in acute in-hospital and chronic outpatient heart failure patients.

Conditions

Congestive Heart Failure(CHF)

Outcome Measures

Primary Outcomes (1)

• Validate the ability of externally monitored thoracic fluid content as a measure of HF.

  Accomplished by comparing the data measured by the Kyma Device(HR, RR, thoracic fluid content) with the same clinical data collected while in the hospital.

  60 days

Secondary Outcomes (1)

• Assess the effectiveness of remote monitoring in detecting outpatient decompensation.

  60 days

Study Arms (2)

Cohort I

EXPERIMENTAL

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.

Device: Kyma Device u-Cor System

Cohort II

EXPERIMENTAL

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.

Device: Kyma Device u-Cor System

Interventions

Kyma Device u-Cor System DEVICE

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 I; Cohort II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort I
• Men or women over 18 years of age
• Admitted for primary diagnosis of HF
• Already assigned for indwelling PA catheter monitoring
• BNP \> 400
• Two of the following: edema, JVP\>7cm, rales
• Currently being assessed with clinically indicated hemodynamic monitoring
• Cohort II
• Men or women over 18 years of age
• Admitted with the primary diagnosis of HF
• BNP \> 400
• Two of the following: edema, JVP\> 7cm, rales
• Patients with or without hemodynamic monitoring in use

You may not qualify if:

• Cohort I and II
• Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive
• Pregnant women

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Lindner Research Center at The Christ Hospitak

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Eugene Chung, MD

  The Lindner Research Center at The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: February 23, 2015
• Study Start: October 1, 2014
• Primary Completion: March 20, 2016
• Study Completion: April 19, 2017
• Last Updated: July 19, 2017

Record last verified: 2015-02

Locations

US (1)