VitalThings Guardian Contactless Monitoring

NCT06083272 | Completed

• 1 other identifier: 527859713
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Depression; Respiratory Failure; Deterioration, Clinical

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparative pulse data

  Will be assessed in 2024, furter details not established.

Other Outcomes (1)

• Acceptance criteria respiratory rate

  Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.

Study Arms (1)

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.

Device: Vitalthings Guardian M10 fixed and M10 mobile

Interventions

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.

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

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients admitted to the Emergency Ward (EW)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VitalThings: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs University Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 39665054 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Clinical Deterioration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Line Pedersen, MD, Phd

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 13, 2023
• Study Start: November 15, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)