Vital Sign Monitor Device Validation - WARD (ViVa-WARD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eske K Aasvang, DMSci
- Phone Number: +4526232076
- Email: Eske.Kvanner.Aasvang.01@regionh.dk
Study Contact Backup
- Name: Christian S Meyhoff, PhD
- Phone Number: +4524910542
- Email: Christian.sylvest.meyhoff@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2400
- Not yet recruiting
- Bispebjerg hospital
-
Contact:
- Christian S Meyhoff
- Phone Number: +4524910542
- Email: Christian.sylvest.meyhoff@regionh.dk
-
Copenhagen, Denmark, 2100
- Recruiting
- Eske Kvanner Aasvang
-
Contact:
- Eske K Aasvang, M.D., DMSci
- Phone Number: +4526232076
- Email: eske.kvanner.aasvang.01@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
76 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of data from novel device and golden standard
Time Frame: 76 hours
|
descriptive statistics using parametric or non-parametric statistics where appropriate
|
76 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WZ-23050470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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