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Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04087070
Enrollment
100
Registered
2019-09-12
Start date
2020-09-28
Completion date
2020-12-31
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accelerometer, Blood Pressure, Electrocardiography, Pediatrics

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.

Interventions

DEVICEBiosignal 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. 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)

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic and diastolic Blood pressureDuring general anesthesia, up to 12 hoursSystolic and diastolic blood pressure by automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).

Secondary

MeasureTime frameDescription
Electrocardiogram waveDuring general anesthesia, up to 12 hoursElectrocardiogram wave
photoplethysmograph waveDuring general anesthesia, up to 12 hoursphotoplethysmograph wave
accelerometer signalDuring general anesthesia, up to 12 hoursaccelerometer signal

Countries

South Korea

Contacts

Primary ContactHee-Soo Kim, MD.PhD
dami0605@snu.ac.kr+82-2-2072-3659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026