NCT06106516

Vital Sign Monitor Device Validation - WARD

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Surgery-Complications
• Medical Complication

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-24
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2023-10-30
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Denmark

Regulatory

• FDA-regulated device study