Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

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.

Study Overview

• Status: Unknown
• Conditions: Blood Pressure; Electrocardiography; Pediatrics; Accelerometer
• Intervention / Treatment: Device: Biosignal measurements

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ASA class I, and II pediatric patients (<12 years) scheduled for elective surgery under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

biosignal derived blood pressure; 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.; PAT(time between R peak of ECG and beginning of the pulse of PPG); PEP(time between R peak of ECG and peak of accelerometer signal); PTT(PAT-PEP)

Device: Biosignal measurements; 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.; PAT(time between R peak of ECG and beginning of the pulse of PPG); PEP(time between R peak of ECG and peak of accelerometer signal); PTT(PAT-PEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic and diastolic Blood pressure	Systolic and diastolic blood pressure by automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).	During general anesthesia, up to 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrocardiogram wave	Electrocardiogram wave	During general anesthesia, up to 12 hours
photoplethysmograph wave	photoplethysmograph wave	During general anesthesia, up to 12 hours
accelerometer signal	accelerometer signal	During general anesthesia, up to 12 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Soo Kim, MD.PhD, Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Publications and helpful links

General Publications

• Yoon Y, Cho JH, Yoon G. Non-constrained blood pressure monitoring using ECG and PPG for personal healthcare. J Med Syst. 2009 Aug;33(4):261-6. doi: 10.1007/s10916-008-9186-0.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 28, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H-1907-088-1049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We art not planning to share individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No