VitalThings Guardian Contactless Monitoring

Respiratory Failure Clinical Trial

— VINCENT  

Official title:

VitalThings Guardian Contactless Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06083272
• Other study ID #: 527859713
• Status: Completed
• Start date: November 15, 2023
• Est. completion date: November 28, 2023

Study information

• Verified date: December 2023
• Source: VitalThings
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Deterioration
• Deterioration, Clinical
• Respiratory Depression
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Norway	St Olavs University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
VitalThings	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance criteria respiratory rate	A limit of agreement of ±1.2 RPM against comparators in setting the respiration rate.	Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Primary	Accuracy	Documented system respiration frequency in RPM for both investigational device and comparator.	Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Secondary	Comparative pulse data	Gather comparative pulse data to be used for retrospective validation of algorithm performance for contactless heart rate measurement/monitoring.	Will be assessed in 2024, furter details not established.