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.
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
OBSERVATIONAL
Enrollment
1,000
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
Eske Kvanner Aasvang
Copenhagen, Denmark
RECRUITINGBispebjerg Hospital
Copenhagen, Denmark
NOT_YET_RECRUITINGAgreement 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
Time frame: 76 hours
Description of data from novel device and golden standard
descriptive statistics using parametric or non-parametric statistics where appropriate
Time frame: 76 hours
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