A Study of Wearable Wireless Device in Addition to Standard Monitoring to Record Vital Signs in Patients in the ICU/Stepdown Unit

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-006416
    Sponsor Protocol Number: 16-006416

About this study

The purpose of the study is to validate wearable device monitoring with standard ICU/stepdown patient vital signs monitoring especially heart rate, telemetry, respiratory rate, blood pressure, and pulse oximetry.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 18 years or over with unselected acute medical or surgical diagnosis admitted to the stepdown/ICU
  • Patients deemed to need continuous vital signs monitoring in the ICU/step-down

Exclusion Criteria:

  • Postoperative cardiac surgery patients
  • Postoperative transplant surgery patients
  • Patient refusal to participate in the study
  • Patient agitation and unable to consent or participate in the study
  • Attending physician on clinical service indicates that patient is not a candidate for the study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ayan Sen, M.D.

Open for enrollment

Contact information:

Parinda Patel CCRP

(480)342-3987

Patel.Parinda@mayo.edu

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CLS-20316798

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