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

July 28, 2015 updated by: Tampere University Hospital
The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Study Monitor used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between invasive and noninvasive blood pressure measurement
Time Frame: 2 hours of continuous measurement at PACU
comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement
2 hours of continuous measurement at PACU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between study monitor Sp02 measurement and current sp02 measurement
Time Frame: 2 hours of continuous measurement at PACU
comparability of measurements at several timepoints recorded as 10s intervals
2 hours of continuous measurement at PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Arvi Yli-Hankala, Professor, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEDIETA2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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