Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

NCT04087070 | Unknown

• 1 other identifier: H-1907-088-1049
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Pediatrics; Electrocardiography; Accelerometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Electrocardiogram wave

  During general anesthesia, up to 12 hours

• photoplethysmograph wave

  During general anesthesia, up to 12 hours

• accelerometer signal

  During general anesthesia, up to 12 hours

Study Arms (1)

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. 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)

Device: Biosignal measurements

Interventions

Biosignal measurements DEVICE

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)

biosignal derived blood pressure

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ASA(American Society of Anesthesiologist) Class I, II
• Scheduled for elective surgery under general anesthesia

You may not qualify if:

• History of cardiovascular disease
• History of thoracic cavity disease
• Unable to measure blood pressure

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related 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. doi: 10.1007/s10916-008-9186-0.

  PMID: 19697692 BACKGROUND

Study Officials

• Hee-Soo Kim, MD.PhD

  Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee-Soo Kim, MD.PhD

CONTACT

+82-2-2072-3659; dami0605@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: September 28, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)