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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06106516
Study type Observational
Source Rigshospitalet, Denmark
Contact Eske K Aasvang, DMSci
Phone +4526232076
Email eske.kvanner.aasvang.01@regionh.dk
Status Recruiting
Phase
Start date October 24, 2023
Completion date December 31, 2028