Vital Sign Monitor Device Validation - WARD

NCT ID: NCT06106516

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-24

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Surgery-Complications Medical Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

No inclusion or exclusion criteria
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Eske Kvanner Aasvang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eske Kvanner Aasvang

Copenhagen, , Denmark

Site Status RECRUITING

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Eske K Aasvang, DMSci

Role: CONTACT

+4526232076

Christian S Meyhoff, PhD

Role: CONTACT

+4524910542

Facility Contacts

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Eske K Aasvang, M.D., DMSci

Role: primary

+4526232076

Christian S Meyhoff

Role: primary

+4524910542

Other Identifiers

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WZ-23050470

Identifier Type: -

Identifier Source: org_study_id

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