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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02357511
Enrollment
30
Registered
2015-02-06
Start date
2015-02-28
Completion date
2015-07-31
Last updated
2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

sensitivity, specificity, novel blood pressure monitor, Saturation

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.

Interventions

DEVICEStudy Monitor used

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between invasive and noninvasive blood pressure measurement2 hours of continuous measurement at PACUcomparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement

Secondary

MeasureTime frameDescription
Relationship between study monitor Sp02 measurement and current sp02 measurement2 hours of continuous measurement at PACUcomparability of measurements at several timepoints recorded as 10s intervals

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026