| Registry | NCT06083272, acronym VINCENT |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 41 (Actual) |
| Sponsor | VitalThings (Industry); collaborators: St. Olavs Hospital |
| Conditions | Respiratory Depression, Respiratory Failure, Deterioration, Clinical |
| Interventions | Vitalthings Guardian M10 fixed and M10 mobile (Device) |
| Dates | start 2023-11-15, primary completion 2023-11-28, completion 2023-11-28, first posted 2023-10-13, last updated 2023-12-05 |
| Locations | 1 site in Norway |
Related Papers Related Patents Related Grants Related Experts
All trials for Respiratory Depression All trials for Respiratory Failure All trials of Vitalthings Guardian M10 fixed and M10 mobile
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Study population | Device: Vitalthings Guardian M10 fixed and M10 mobile | 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| St Olavs University Hospital | Trondheim | Norway |