Vital Sign Monitor Device Validation - WARD
NCT06106516 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2025-04-06
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.
Conditions
- Surgery-Complications
- Medical Complication
Interventions
- DEVICE
-
novel vital sign monitor
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
Sponsors & Collaborators
-
Bispebjerg Hospital
collaborator OTHER -
Rigshospitalet, Denmark
lead OTHER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-24
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- Denmark
Study Locations
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