VitalThings Guardian Contactless Monitoring

VitalThings41 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Depression Respiratory Failure Deterioration, Clinical

Interventions

Vitalthings Guardian M10 fixed and M10 mobileDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

St Olavs University Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

Accuracy

Documented system respiration frequency in RPM for both investigational device and comparator.

Time frame: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.

Secondary Outcomes

Comparative pulse data

Gather comparative pulse data to be used for retrospective validation of algorithm performance for contactless heart rate measurement/monitoring.

Time frame: Will be assessed in 2024, furter details not established.

Data from ClinicalTrials.gov

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