VitalThings Guardian Contactless Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Accuracy
Study Overview
Brief Summary
This is a confirmatory study without any intervention. It is an uncontrolled, non-randomized and open-label study with measurements made with comparators, and it has a preset hypothesis for the primary endpoint. There are no similar devices to VitalThings Guardian M10 / M10 mobile on the market, consequently one or more different types of devices must be used as comparators.
Detailed Description
The purpose of the clinician investigation is to validate a claim made for the investigational device performance. The objective is to confirm that the device performs at +/- 1.2 respirations per minute (RPM) accuracy against the identified comparator device, and compare performance to the standard of care as documented in the literature. The study will be conducted with patients admitted to the emergency ward after the initial treatment and examination.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult patients admitted to the Emergency Ward (EW)
Exclusion Criteria
- •Under age (below 18 years) and subjects not able to provide informed consent themselves. Subjects dismissed from the EW rooms within 30 minutes from first registration are removed from the study.
Outcomes
Primary Outcomes
Accuracy
Time Frame: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Documented system respiration frequency in RPM for both investigational device and comparator.
Secondary Outcomes
- Comparative pulse data(Will be assessed in 2024, furter details not established.)