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

Not Applicable
Completed
Conditions
Blood Pressure
Interventions
Device: Study Monitor used
Registration Number
NCT02357511
Lead Sponsor
Tampere University Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Study goupStudy Monitor usedVital 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.
Primary Outcome Measures
NameTimeMethod
Relationship between invasive and noninvasive blood pressure measurement2 hours of continuous measurement at PACU

comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement

Secondary Outcome Measures
NameTimeMethod
Relationship between study monitor Sp02 measurement and current sp02 measurement2 hours of continuous measurement at PACU

comparability of measurements at several timepoints recorded as 10s intervals

Trial Locations

Locations (1)

Tampere University Hospital

🇫🇮

Tampere, Finland

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