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

Not Applicable

Completed

• Conditions: Blood Pressure

• 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.

Study Timeline

• Study First Submitted: 2015-01-22
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-29

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

Primary Outcome Measures

Name	Time	Method
Relationship between invasive and noninvasive blood pressure measurement	2 hours of continuous measurement at PACU	comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement

Secondary Outcome Measures

Name	Time	Method
Relationship between study monitor Sp02 measurement and current sp02 measurement	2 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