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Vital Sign Monitor Device Validation - WARD (ViVa-WARD)

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Rigshospitalet

Status

Enrolling

Conditions

Surgery-Complications
Medical Complication

Treatments

Device: novel vital sign monitor

Study type

Observational

Funder types

Other

Identifiers

NCT06106516
WZ-23050470

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

No inclusion or exclusion criteria

Trial contacts and locations

2

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Central trial contact

Eske K Aasvang, DMSci; Christian S Meyhoff, PhD

Data sourced from clinicaltrials.gov

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