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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357511
• Other study ID #: MEDIETA2015
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: July 28, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Study Monitor used

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between invasive and noninvasive blood pressure measurement	comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement	2 hours of continuous measurement at PACU	No
Secondary	Relationship between study monitor Sp02 measurement and current sp02 measurement	comparability of measurements at several timepoints recorded as 10s intervals	2 hours of continuous measurement at PACU	No