Vital Sign Monitor Device Validation - WARD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Humans with or without medical or surgical complications in or out of hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
novel vital sign monitor
DeviceDevices 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 hoursSecondary outcomes
1
Description of data from novel device and golden standard
descriptive statistics using parametric or non-parametric statistics where appropriate
Time frame
76 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Bispebjerg Hospital
Collaborator
Source ClinicalTrials.gov