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Clinical Trials/NCT04087070
NCT04087070
Unknown
Not Applicable

Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

Seoul National University Hospital1 site in 1 country100 target enrollmentSeptember 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
Seoul National University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Systolic and diastolic Blood pressure
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study is to estimate blood pressure in pediatric patients using a non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest.

Detailed Description

Blood pressure is measured by an automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands). Following parameters will be measured by non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest and will be used to estimate the biosignal derived blood pressure. 1. PAT(time between R peak of ECG and beginning of the pulse of PPG) 2. PEP(time between R peak of ECG and peak of accelerometer signal) 3. PTT(PAT-PEP) The algorithm of the biosignal derived blood pressure will be made using the MATLAB 2016b(Mathworks, Natick, MA) program. The agreement between the non-invasive blood pressure and the biosignal derived blood pressure will be analyzed using Cohen's Kappa or Bland-Altman plot.

Registry
clinicaltrials.gov
Start Date
September 28, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • ASA(American Society of Anesthesiologist) Class I, II
  • Scheduled for elective surgery under general anesthesia

Exclusion Criteria

  • History of cardiovascular disease
  • History of thoracic cavity disease
  • Unable to measure blood pressure

Outcomes

Primary Outcomes

Systolic and diastolic Blood pressure

Time Frame: During general anesthesia, up to 12 hours

Systolic and diastolic blood pressure by automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).

Secondary Outcomes

  • photoplethysmograph wave(During general anesthesia, up to 12 hours)
  • Electrocardiogram wave(During general anesthesia, up to 12 hours)
  • accelerometer signal(During general anesthesia, up to 12 hours)

Study Sites (1)

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