Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

Blood Pressure Clinical Trial

Official title:

Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04087070
• Other study ID #: H-1907-088-1049
• Status: Not yet recruiting
• Start date: September 28, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim, MD.PhD
• Phone: +82-2-2072-3659
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Accelerometer
• Blood Pressure
• Electrocardiography
• Pediatrics

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Electrocardiogram wave	Electrocardiogram wave	During general anesthesia, up to 12 hours
Secondary	photoplethysmograph wave	photoplethysmograph wave	During general anesthesia, up to 12 hours
Secondary	accelerometer signal	accelerometer signal	During general anesthesia, up to 12 hours