Vital Sign Monitor Device Validation - WARD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: novel vital sign monitor.
- Who it may be relevant to
- Registry conditions: Surgery-Complications, Medical Complication. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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
Primary outcome measures
- Agreement between vital sign data from novel device and golden standard [Time frame: 76 hours]
Secondary outcome measures (1)
- Description of data from novel device and golden standard [Time frame: 76 hours]
Eligibility criteria
No inclusion or exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 2 centers
- Eske Kvanner Aasvang — Copenhagen
- Bispebjerg Hospital — Copenhagen
Identifiers
NCT: NCT06106516 · WZ-23050470