VINCENT: VitalThings Guardian Contactless Monitoring

Sponsor

VitalThings (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06083272

Collaborator

St. Olavs Hospital (Other)

Enrollment

Anticipated Duration (Days)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Depression Respiratory Failure Deterioration, Clinical	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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

VitalThings Guardian Contactless Monitoring

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Nov 25, 2023

Anticipated Study Completion Date :

Dec 8, 2023

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Accuracy [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 Outcome Measures

Comparative pulse data [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 Outcome Measures

Acceptance criteria respiratory rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.