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WBPS A Prospective, Method Comparison, Proof of Concept Study

NCT ID: NCT02934386

Last Updated: 2017-11-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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WinMedical WinPack device

50 volunteers undergoing experimental protocol according to IEEE 1708:2014 standard

Group Type EXPERIMENTAL

WinMedical WinPack device

Intervention Type DEVICE

Interventions

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WinMedical WinPack device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cyril Pellaton, Dr

Role: PRINCIPAL_INVESTIGATOR

HNE - Hôpital Neuchâtelois, Site de Pourtalès

Locations

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HNE - Hôpital Neuchâtelois, Site de Pourtalès

Neuchâtel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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WBPS

Identifier Type: -

Identifier Source: org_study_id