Surgery-Complications Clinical Trial
— ViVa-WARDOfficial title:
Vital Sign Monitor Device Validation - 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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | No inclusion or exclusion criteria |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen | |
Denmark | Eske Kvanner Aasvang | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Bispebjerg Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Description of data from novel device and golden standard | descriptive statistics using parametric or non-parametric statistics where appropriate | 76 hours |