Skip to main content
OpenTrials
Completed

NCT Number: NCT02934386

WBPS A Prospective, Method Comparison, Proof of Concept Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HNE - Hôpital Neuchâtelois, Site de Pourtalès

Neuchâtel, 2000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >18 years
  • Informed Consent
  • Compliant and able to protocol manoeuvres

Exclusion criteria

  • Blood pressure difference between to arms >15mmHg
  • Current or history of tobacco smoking (for the last 5 years, > 5 cigarettes per day),
  • Current alcohol or drug abuse (>4 units per day),
  • Unstable cardiac condition (myocardial infarction < 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
  • Severe anaemia (haemoglobin <100g/l)
  • Oxygen therapy
  • Lesion or deficiency on left hand, preventing to perform handgrip exercises
  • Lesion or deficiency on both legs, preventing to perform leg extension exercise

Treatment and study plan

WinMedical WinPack device

Device

Primary outcomes

  1. Assessment of the accuracy of a novel algorithm to extract BP estimates from data acquired by the WinPack system, when compared to gold-standard BP devices, with respect to limits of agreement as stated by the IEEE 1708:2014 standard

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Industry

Registry information

Official study title

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

Acronym: WBPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Nov 27, 2017

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.

Published trials that share one or more normalized conditions with this study.