NCT06083272

VitalThings Guardian Contactless Monitoring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: VitalThings · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Depression
• Respiratory Failure
• Deterioration, Clinical

Interventions

Type	Name	Description
DEVICE	Vitalthings 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.

Timeline

• Start date: 2023-11-15
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2023-10-13
• Last updated: 2023-12-05

Locations

1 site across 1 country: Norway