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NCT Number: NCT06106516

Vital Sign Monitor Device Validation - WARD

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.

Recruiting

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Key information

Conditions

Surgery-Complications Medical Complication

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

No inclusion or exclusion criteria

Treatment and study plan

novel vital sign monitor

Device

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

Primary outcomes

  1. Agreement between vital sign data from novel device and golden standard

    Time frame: 76 hours

    agreement between novel device and golden standard or clinical standard devices, assess by bias and limits of agreement

Secondary outcomes

  1. Description of data from novel device and golden standard

    Time frame: 76 hours

    descriptive statistics using parametric or non-parametric statistics where appropriate

Study contacts

Contact information is provided by the study sponsor or research team.

Christian S Meyhoff, PhD

CONTACT

[email protected]

+4524910542

Eske K Aasvang, DMSci

CONTACT

[email protected]

+4526232076

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Acronym: ViVa-WARD

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 30, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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