Vital Sign Monitor Device Validation - WARD
ViVa-WARD
1 other identifier
observational
1,000
1 country
2
Brief 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 standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2023
CompletedStudy Start
First participant enrolled
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 6, 2025
April 1, 2025
5.2 years
October 24, 2023
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
76 hours
Secondary Outcomes (1)
Description of data from novel device and golden standard
76 hours
Interventions
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
Eligibility Criteria
Humans with or without medical or surgical complications in or out of hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Bispebjerg Hospitalcollaborator
Study Sites (2)
Eske Kvanner Aasvang
Copenhagen, 2100, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2023
First Posted
October 30, 2023
Study Start
October 24, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 6, 2025
Record last verified: 2025-04