NCT02934386

WBPS A Prospective, Method Comparison, Proof of Concept Study

Validation of the WBPS - Wrist Blood Pressure System A Prospective, Method Comparison, Proof of Concept Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to the existing CE-marked WinPack device, compared to two reference devices (one oscillometric and one volume-clamp device), in healthy subjects and patients undergoing a standardized physical-activity hypertensive protocol.

Detailed description

Current standard for patient monitoring in acute care such as intensive care units (ICU), operating rooms (OR) or emergency rooms (ER) is the use of expensive, bulky and uncomfortable monitors. Unfortunately, once discharged from the acute care setting and transferred to a general division for example (low acuity), patients are left with manual measurements of vital signs every 4 to 6 hours, depending on the available resources in nursing. Furthermore, these measurements reflect only the results of the time the measurement is taken (spot check). The combination of manual spot checks and lack of innovative medical technology in 60% of hospital care settings (all non-ICUs and non-OR) represents an important limitation to patient follow-up, with its associated risks and costs. In particular, when referring to the monitoring of blood pressure (BP), current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm. Based on oscillometric technique, occlusive cuffs not only are uncomfortable, but they provide only intermittent measurements, with the inability to provide a full view of the BP regulation landscape. Therefore, un-detected hypertensive events can be omitted, putting the patient at risk. The continuous, comfortable and portable measurement of BP in low acuity hospital departments is a major unsolved problem of modern healthcare systems with regards to patient monitoring and safety. Winmedical (device manufacturer) commercializes a wearable multi-parametric modular medical system, WinPack, to deliver continuous real-time monitoring and recording of vital signs, such as electrocardiography (ECG), respiration rate, BP, blood oxygen saturation, body temperature, and posture, in low-acuity departments to increase the overall clinical performance. A new algorithm to process the raw physiological signals acquired by the WinPack to provide more accurate and more continuous BP measurement is now to be tested.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	WinMedical WinPack device

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-10-17
• Last updated: 2017-11-27

Locations

1 site across 1 country: Switzerland