Vital Sign Monitor Device Validation - WARD

Surgery-Complications Clinical Trial

— ViVa-WARD  

Official title:

Vital Sign Monitor Device Validation - WARD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106516
• Other study ID #: WZ-23050470
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Medical Complication

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