A Study of a Wearable Vital Signs Monitoring Device for the Detection of Systemic Inflammatory Response Syndrome and Sepsis in Stem Cell Transplant Patients
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 15-003692
Sponsor Protocol Number: 15-003692
About this study
The purpose of this study is to validate the effectiveness of the ZephyrLife Home monitoring device compared with standard ICU or stepdown vital signs monitoring, especially for heart rate, respiratory rate and temperature as systemic (whole body) inflammatory response syndrome or sepsis ( whole body infection) markers in stem cell transplant patients.
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
- History of stem cell transplantation
- Has continuous vital signs monitoring in the ICU/step-down unit
Exclusion Criteria
- Refusal to participate in the study
- Agitation
- 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