Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

Scripps Translational Science Institute

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT02343523

14-6510

Details and patient eligibility

About

The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.

Full description

The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.

Enrollment: 13 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over age 18

• Own, and comfortable using, a home computer with internet access (Phase 2 only)

• Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:

  1. Symptoms:

     • Onset or worsening of dyspnea within the past 2 weeks

  2. Physical exam (at least 1 present):

     • Rales/ Crackles on auscultation
     • Elevated JVP > 10 cmH2O
     • Weight gain
     • LE edema

  3. Diagnostic imaging/ labs (at least 1 present):

     • Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
     • Elevated BNP or NT-pro-BNP (age-adjusted)

Exclusion criteria

• Psychological or social situation that would make the study difficult for the patient
• Inability to consent
• Chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
• Pregnant women
• Pneumonia - currently, or within the past 30 days
• Non-cardiogenic pulmonary edema (e.g. ARDS)
• Interstitial lung disease
• End-stage renal disease and on Hemodialysis