Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

• Conditions: Accelerometer; Blood Pressure; Pediatrics; Electrocardiography
• Interventions: Device: Biosignal measurements

• Registration Number: NCT04087070
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23
• Study Start: 2020-09-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biosignal derived blood pressure	Biosignal measurements	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)

Primary Outcome Measures

Name	Time	Method
Systolic and diastolic Blood pressure	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 Outcome Measures

Name	Time	Method
photoplethysmograph wave	During general anesthesia, up to 12 hours	photoplethysmograph wave
Electrocardiogram wave	During general anesthesia, up to 12 hours	Electrocardiogram wave
accelerometer signal	During general anesthesia, up to 12 hours	accelerometer signal

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of