Respiratory DepressionVINCENTNCT06083272
VitalThings Guardian Contactless Monitoring
An observational study of Respiratory Depression and Respiratory Failure, run by VitalThings at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression, Respiratory Failure, Deterioration, Clinical
- What is being tested?
- Vitalthings Guardian M10 fixed and M10 mobile
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2023to 28 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients admitted to the Emergency Ward (EW)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Vitalthings Guardian M10 fixed and M10 mobile
- Keywords
- respiratory rate, patient monitoring, ultra wideband radar, contactless monitoring, medical device regulation
- Medical subject headings
- Respiratory Insufficiency, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitalthings Guardian M10 fixed and M10 mobileDevice
Also called Nox T3s (NOX Medical, Alpharetta, GA, USA ) with a Nonin 3150 pulse oximeter (Nonin Medical Inc., MN, USA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vitalthings Guardian M10 fixed and M10 mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Documented system respiration frequency in RPM for both investigational device and comparator.
Measured: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.
Secondary outcomes (1)
Comparative pulse data
Gather comparative pulse data to be used for retrospective validation of algorithm performance for contactless heart rate measurement/monitoring.
Measured: Will be assessed in 2024, furter details not established.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Nov 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- VitalThings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Line Pedersen, MD, Phd, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083272
- Sponsor's protocol ID
- 527859713
- Acronym
- VINCENT
- Status last verified
- Dec 2023
- First submitted
- 8 Oct 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39665054
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VitalThings Guardian Contactless Monitoring
- ClinicalTrials.gov ID
- NCT06083272
- Acronym / sponsor ID
- VINCENT / 527859713
- Keywords
- respiratory rate, patient monitoring, ultra wideband radar, contactless monitoring, medical device regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- VitalThingsIndustry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Device: Vitalthings Guardian M10 fixed and M10 mobileThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients admitted to the Emergency Ward (EW)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitalthings Guardian M10 fixed and M10 mobileAlso: Nox T3s (NOX Medical, Alpharetta, GA, USA ) with a Nonin 3150 pulse oximeter (Nonin Medical Inc., MN, USA)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. | Device | Study population |
Primary outcome
Accuracy
Time frame: 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.
1 secondary outcome
Comparative pulse data
Time frame: Will be assessed in 2024, furter details not established.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 39665054Toften 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line Pedersen, MD, Phd principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Depression and Respiratory Failure, run by VitalThings at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Will be assessed after last participant has finished the investigation. One interim analysis in first week is planned.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06083272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.