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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04087070
Other study ID # H-1907-088-1049
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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