An observational study in Surgery-Complications and Medical Complication, sponsored by Rigshospitalet, Denmark. Recruiting at 2 sites in Denmark. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Rigshospitalet, Denmark · Observational
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.
Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Humans with or without medical or surgical complications in or out of hospital
No inclusion or exclusion criteria
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
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
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
Plan to share: Undecided — data can be shared upon reasonable request
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Rigshospitalet, Denmark