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OpenTrials
Completed

NCT Number: NCT02357511

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Monitor used

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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