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VitalThings Guardian Contactless Monitoring

NCT ID: NCT06083272

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2023-11-28

Brief Summary

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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

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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

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Respiratory Depression Respiratory Failure Deterioration, Clinical

Keywords

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respiratory rate patient monitoring ultra wideband radar contactless monitoring medical device regulation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

The study population is comprised of two subgroups;

1. 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.
2. 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.

Vitalthings Guardian M10 fixed and M10 mobile

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

VitalThings

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Line Pedersen, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

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St Olavs University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Toften S, Kjellstadli JT, Kvaerness J, Pedersen L, Laugsand LE, Thu OKF. Contactless and continuous monitoring of respiratory rate in a hospital ward: a clinical validation study. Front Physiol. 2024 Nov 27;15:1502413. doi: 10.3389/fphys.2024.1502413. eCollection 2024.

Reference Type DERIVED
PMID: 39665054 (View on PubMed)

Other Identifiers

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527859713

Identifier Type: -

Identifier Source: org_study_id