Caretaker Vitalstream Self-Calibration Comparison Study

About

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 via 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.

Eligibility Criteria

Inclusion Criteria

Subjects shall be ≥ 18 years of age, be able and willing to participate and have given consent.

Exclusion Criteria

  1. Unable to give consent
  2. <18 years of age
  3. Have known pregnancy
  4. Have broken, open or infected skin located on any fingers, hands or wrists that will be used for cuff placement
  5. Have a resting systolic blood pressure greater than 200 mmHg
  6. Have had a cardiac issue or event in the past 6 months
  7. Have a history of deep vein thrombosis
  8. Have a history of bleeding disorders
  9. Contraindicated to clonidine
  10. Not meeting any of the inclusion criteria

 

 

Primary Investigator

Damon R. Kuehl, MD

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Damon Kuehl, MD, is an emergency medicine physician with over 20 years of clinical and research experience. He is 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 is 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.

Damon R. Kuehl, MD

Contact Information

Bridget Switzer, MPH
Clinical Research Coordinator 

Cameron Hooten, BS
Clinical Research Coordinator