Blood PressureNCT04087070
Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
An observational study of Blood Pressure and Pediatrics, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Pediatrics, Electrocardiography
- What is being tested?
- Biosignal measurements
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: ASA class I, and II pediatric patients (<12 years) scheduled for elective surgery under general anesthesia
Who may be able to join
- ASA(American Society of Anesthesiologist) Class I, II
- Scheduled for elective surgery under general anesthesia
Who cannot join
- History of cardiovascular disease
- History of thoracic cavity disease
- Unable to measure blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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)
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.
- Conditions
- Blood Pressure, Pediatrics, Electrocardiography, Accelerometer
- Being tested
- Biosignal measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosignal measurementsDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Biosignal measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During general anesthesia, up to 12 hours
Secondary outcomes (3)
Electrocardiogram wave
Electrocardiogram wave
Measured: During general anesthesia, up to 12 hours
photoplethysmograph wave
photoplethysmograph wave
Measured: During general anesthesia, up to 12 hours
accelerometer signal
accelerometer signal
Measured: During general anesthesia, up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start28 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD.PhD, Principal investigator, Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087070
- Sponsor's protocol ID
- H-1907-088-1049
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We art not planning to share individual participant data available to other researchers
Publications
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.
PubMed 19697692
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
- ClinicalTrials.gov ID
- NCT04087070
- Acronym / sponsor ID
- H-1907-088-1049
- Conditions
- Blood Pressure, Pediatrics, Electrocardiography, Accelerometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biosignal derived blood pressure | – | Device: Biosignal measurementsBlood 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) |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- ASA class I, and II pediatric patients (<12 years) scheduled for elective surgery under general anesthesia
Key inclusion criteria (2 listed)
- ASA(American Society of Anesthesiologist) Class I, II
- Scheduled for elective surgery under general anesthesia
Key exclusion criteria (3 listed)
- History of cardiovascular disease
- History of thoracic cavity disease
- Unable to measure blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosignal measurementsFollowing 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 derived blood pressure |
Primary outcome
Systolic and diastolic Blood pressure
Time frame: 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).
3 secondary outcomes
Electrocardiogram wave
Time frame: During general anesthesia, up to 12 hours
photoplethysmograph wave
Time frame: During general anesthesia, up to 12 hours
accelerometer signal
Time frame: During general anesthesia, up to 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Background: PubMed 19697692Yoon 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.
- Individual participant dataSharing planned: No. We art not planning to share individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim, MD.PhD principal investigator
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Pediatrics, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Soo Kim, MD.PhD (+82-2-2072-3659, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic Blood pressure (time frame: During general anesthesia, up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.