VitalThings Guardian Contactless Monitoring (VINCENT)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Respiratory Depression; Deterioration, Clinical
• Intervention / Treatment: Device: Vitalthings Guardian M10 fixed and M10 mobile

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The EW study population is beneficial to the study as it offers an unfiltered study population with a broad cross-section of potential admission reasons and diagnoses in a short period of time. Any patient that needs acute treatment/examination (typically triaged as "red") will per standard of care go into dedicated EW rooms and not be part of this study. The safe participation of each patient will be evaluated by a specialist in emergency medicine (PI) before invitation to participate.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study population; The study population is comprised of two subgroups; Adult patients admitted to the Emergency Ward (EW). Patients are recruited after the treatment and examination in EW are finished and the patient is waiting for transfer to a hospital ward.; If there is a prolonged period of waiting time for a control blood sample, chest CT or any other examination which usually incurs significant waiting time in the EW. This will be evaluated by a specialist in emergency medicine based on the premise that the inclusion in the study will not delay or interfere with these examinations.

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.; Other Names: Nox T3s (NOX Medical, Alpharetta, GA, USA ) with a Nonin 3150 pulse oximeter (Nonin Medical Inc., MN, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: VitalThings
• Collaborators: St. Olavs Hospital
• Investigators: Principal Investigator: Line Pedersen, MD, Phd, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: respiratory rate; patient monitoring; ultra wideband radar; contactless monitoring; medical device regulation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Disease Progression; Respiratory Insufficiency; Clinical Deterioration
• Other Study ID Numbers: 527859713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No