Vital Sign Monitor Device Validation - WARD

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Agreement between vital sign data from novel device and golden standard — 76 hours
  agreement between novel device and golden standard or clinical standard devices, assess by bias and limits of agreement

Trial sites (2)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark