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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06106516
Other study ID # WZ-23050470
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 24, 2023
Est. completion date December 31, 2028

Study information

Verified date October 2023
Source Rigshospitalet, Denmark
Contact Eske K Aasvang, DMSci
Phone +4526232076
Email eske.kvanner.aasvang.01@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility No inclusion or exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen
Denmark Eske Kvanner Aasvang Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 76 hours
Secondary Description of data from novel device and golden standard descriptive statistics using parametric or non-parametric statistics where appropriate 76 hours