Caretaker Vitalstream Self-Calibration Comparison Study

This study explores how wearable remote monitoring can support patients with heart failure after emergency department discharge. Researchers are evaluating whether continuous, non-invasive monitoring can help improve care during the critical post-discharge period.

Category
Blood, Heart, and Circulation

Age Requirement
Adults (18 years and older)

About This Study

Summary

This pilot study aims to assess the feasibility of remotely monitoring patients with heart failure who have been discharged from the emergency department. The goal is to prepare for a larger, randomized study evaluating the impact of remote monitoring on hospital admission and readmission rates for patients with acute decompensated heart failure (ADHF).

The Vitalstream™ device, which has received FDA clearances for continuous and non-invasive monitoring of blood pressure, heart rate, and respiration, will be used in this study. Utilizing Pulse Decomposition Analysis (PDA) technology, Vitalstream™ captures hemodynamic data through a low-pressure cuff worn on the third finger. This data is wirelessly transmitted to a remote unit, allowing continuous monitoring for up to 24 hours on a single charge. By integrating remote monitoring, we aim to explore how real-time physiological data can better support patient outcomes post-discharge.

To be included in this study, participants must be / have

  • Adults 18 years or older
  • Able and willing to participate
  • Consent provided

To be included in this study, participants must not be / have

  • Unable to give consent
  • Less than18 years of age
  • Pregnant
  • Broken, open, or infected skin located on any fingers, hands, or wrists that will be used for cuff placement
  • A resting systolic blood pressure greater than 200 mmHg
  • Had a cardiac issue or event in the past 6 months
  • A history of deep vein thrombosis
  • A history of bleeding disorders
  • Contraindicated to clonidine
  • Not meeting any of the inclusion criteria
Keywords
Emergency department; Heart failure

For More About This Study or To Ask About Participation

Bridget Switzer, MPH
Clinical Research Coordinator

Cameron Hooten, BS
Clinical Research Coordinator

Additional Information

Lead scientist at Carilion Clinic


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Damon Kuehl, MD, is an emergency medicine physician with more than 20 years of clinical and research experience. He's an associate professor of emergency medicine at the Virginia Tech Carilion School of Medicine and vice chair of research and academic affairs at Carilion Clinic. He's board-certified by the American Board of Emergency Medicine in emergency medicine. He attended the University of Minnesota for medical school and completed his emergency training at Stanford University. He completed a health research fellowship in health policy and economics at OHSU.

Official title of study

Caretaker Vitalstream Self-Calibration Comparison Study

Funding mechanism