Medical Complication, Surgery-Complications
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEnovel 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
Sponsors
Bispebjerg Hospital
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
No inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of data from novel device and golden standard | 76 hours | descriptive statistics using parametric or non-parametric statistics where appropriate |
Countries
Denmark
Contacts
Primary ContactEske K Aasvang, DMSci
Backup ContactChristian S Meyhoff, PhD
Outcome results
None listed