A Study of Wearable Wireless Device in Addition to Standard Monitoring to Record Vital Signs in Patients in the ICU/Stepdown Unit
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Ayan Sen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available