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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | The study population is comprised of two subgroups;
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Line Pedersen, MD, Phd | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs University Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39665054 | Derived | 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. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000075902 | Clinical Deterioration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |