Surgery-ComplicationsViVa-WARDNCT06106516
Vital Sign Monitor Device Validation - WARD
An observational study of Surgery-Complications and Medical Complication, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting. Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgery-Complications, Medical Complication
- What is being tested?
- novel vital sign monitor
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 24 Oct 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Humans with or without medical or surgical complications in or out of hospital
No inclusion or exclusion criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Eske Kvanner Aasvang
Copenhagen, 2100
Eske K Aasvang, M.D., DMSci, +4526232076, eske.kvanner.aasvang.01@regionh.dk
- Not yet recruiting
Bispebjerg Hospital
Copenhagen, 2400
Christian S Meyhoff, +4524910542, Christian.sylvest.meyhoff@regionh.dk
About this study
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.
Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.
Read the detailed description
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.
Patients: up to 1000 medical and/or surgical patients will be included. Intervention: Studies with various wireless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device. Other statistical assessments of agreement may be chosen as secondary outcomes, dependent on the data-structure
Setting: the study will be carried out in up to 76 hours with collection of vital sign data pre-, intra or postoperatively.
- Conditions
- Surgery-Complications, Medical Complication
- Being tested
- novel vital sign monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel vital sign monitorDevice
Devices that are to be introduced into the clinic but where data from clinical relevant conditions such as complications are lacking to assess the validity under clinical conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between vital sign data from novel device and golden standard
agreement between novel device and golden standard or clinical standard devices, assess by bias and limits of agreement
Measured: 76 hours
Secondary outcomes (1)
Description of data from novel device and golden standard
descriptive statistics using parametric or non-parametric statistics where appropriate
Measured: 76 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start24 Oct 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106516
- Sponsor's protocol ID
- WZ-23050470
- Acronym
- ViVa-WARD
- Status last verified
- Apr 2025
- First submitted
- 24 Oct 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Sign Monitor Device Validation - WARD
- ClinicalTrials.gov ID
- NCT06106516
- Acronym / sponsor ID
- ViVa-WARD / WZ-23050470
- Conditions
- Surgery-Complications, Medical Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 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.
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.
Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.
Detailed description
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.
Patients: up to 1000 medical and/or surgical patients will be included. Intervention: Studies with various wireless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device. Other statistical assessments of agreement may be chosen as secondary outcomes, dependent on the data-structure
Setting: the study will be carried out in up to 76 hours with collection of vital sign data pre-, intra or postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Humans with or without medical or surgical complications in or out of hospital
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 |
|---|---|---|
| novel vital sign monitorDevices that are to be introduced into the clinic but where data from clinical relevant conditions such as complications are lacking to assess the validity under clinical conditions | Device | – |
Primary outcome
Agreement between vital sign data from novel device and golden standard
Time frame: 76 hours
agreement between novel device and golden standard or clinical standard devices, assess by bias and limits of agreement
1 secondary outcome
Description of data from novel device and golden standard
Time frame: 76 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided. data can be shared upon reasonable request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery-Complications and Medical Complication, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eske K Aasvang, DMSci (+4526232076, eske.kvanner.aasvang.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between vital sign data from novel device and golden standard (time frame: 76 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.