Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor

NCT ID: NCT02357511

Last Updated: 2015-07-29

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-07-31

Brief Summary

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The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

Detailed Description

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A novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. Monitor captures also saturation and ECG, which are compared to traditional monitoring.

Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Study goup

Vital values are being measured for the time of two hours at postoperative setting at postanesthesia care unit. A novel method is compared to golden standard: invasive measurement. Also Saturation measurements are being compared between standard and study monitor.

Group Type EXPERIMENTAL

Study Monitor used

Intervention Type DEVICE

Interventions

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Study Monitor used

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* subjected to operative treatment with the need for invasive blood pressure measurement
* spontaneous ventilation
* able to give informed consent

Exclusion Criteria

* denial by patient
* pacemaker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arvi Yli-Hankala, Professor

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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MEDIETA2015

Identifier Type: -

Identifier Source: org_study_id

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