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OpenTrials
Completed

NCT Number: NCT06083272

VitalThings Guardian Contactless Monitoring

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.

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Key information

Conditions

Respiratory Depression Clinical Deterioration Deterioration, Clinical Disease Attributes Disease Progression Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Olavs University Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitalthings Guardian M10 fixed and M10 mobile

Device

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)

Primary outcomes

  1. Accuracy

    Time frame: 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 outcomes

  1. Comparative pulse data

    Time frame: 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 outcomes

  1. Acceptance criteria respiratory rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VitalThings

Industry

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: VINCENT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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