Deterioration, Clinical, Respiratory Depression, Respiratory Failure
Conditions
Keywords
respiratory rate, patient monitoring, ultra wideband radar, contactless monitoring, medical device regulation
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.
Interventions
DEVICEVitalthings Guardian M10 fixed and M10 mobile
VitalThings Guardian M10 / M10 mobile (VitalThings, Norway), are the investigational devices. These are the same technical devices made in two versions: one wall-mounted (VitalThings Guardian M10 fixed) and one mounted on a trolley (VitalThings Guardian M10 mobile). The Nox T3s and Nonin will be used as comparator devices.
Sponsors
St. Olavs Hospital
VitalThings
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparative pulse data | Will be assessed in 2024, furter details not established. | Gather comparative pulse data to be used for retrospective validation of algorithm performance for contactless heart rate measurement/monitoring. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptance criteria respiratory rate | Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned. | A limit of agreement of ±1.2 RPM against comparators in setting the respiration rate. |
Countries
Norway
Outcome results
None listed