- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087070
Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hee-Soo Kim, MD.PhD
- Phone Number: +82-2-2072-3659
- Email: dami0605@snu.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
During general anesthesia, up to 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrocardiogram wave
Time Frame: During general anesthesia, up to 12 hours
|
Electrocardiogram wave
|
During general anesthesia, up to 12 hours
|
photoplethysmograph wave
Time Frame: During general anesthesia, up to 12 hours
|
photoplethysmograph wave
|
During general anesthesia, up to 12 hours
|
accelerometer signal
Time Frame: During general anesthesia, up to 12 hours
|
accelerometer signal
|
During general anesthesia, up to 12 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hee-Soo Kim, MD.PhD, Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-1907-088-1049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blood Pressure
-
DongGuk UniversityActive, not recruitingHypertension | Blood Pressure | Ambulatory Blood Pressure | Home Blood Pressure MeasurementKorea, Republic of
-
ROX Medical, Inc.CompletedHypertension | Blood Pressure, High | Blood Pressure, Resistant | Blood Pressure, UncontrolledUnited Kingdom, Netherlands, Belgium
-
SE HealthCentre for Aging and Brain Health InnovationCompletedHypertension | Blood Pressure | Hypotension | High Blood Pressure | Low Blood PressureCanada
-
University of JordanCompletedBlood Pressure | Heart Rate | Airway PressureJordan
-
Istituto Auxologico ItalianoRecruitingArterial Hypertension | Ambulatory Blood Pressure Monitoring | Blood Pressure Determination | Home Blood Pressure MonitoringItaly
-
RadiRad Co., Ltd.Hualien Tzu Chi General HospitalNot yet recruitingBlood Pressure
-
Riphah International UniversityRecruiting
-
The George InstituteUniversity of Abuja Teaching HospitalNot yet recruiting
-
GE HealthcareNot yet recruiting
-
Guangdong Provincial People's HospitalRecruiting
Clinical Trials on Biosignal measurements
-
National Taiwan University HospitalNational Tsing Hua UniversityUnknown
-
University Health Network, TorontoRecruitingRespiratory Insufficiency | Lung Injury | Mechanical Ventilation Complication | Diaphragm Injury | Abdominal Muscle StrainedCanada
-
Marmara UniversityRecruitingCerebral Palsy | Infant, Premature, Diseases | Preterm Birth ComplicationTurkey
-
Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Infant, Premature, Diseases | Neurologic Disorder | Infant, Newborn, Disease | Infant Development | Development Delay | Infant, Very Low Birth Weight | Infant, Small for Gestational Age | Infant AsphyxiaTurkey
-
Pamukkale UniversityCompletedDiabetes Mellitus, Type 2 | Periodontitis | Coronary Heart Disease | Arterial StiffnessTurkey
-
Skulpt, Inc.National Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedAmyotrophic Lateral Sclerosis (ALS)United States
-
Pamukkale UniversityCompletedPeriodontal InflammationTurkey
-
Vanderbilt UniversityCompleted
-
University Hospital, Strasbourg, FranceRecruiting
-
Kahramanmaras Sutcu Imam UniversityCompletedInfant, Premature, Diseases | Sensory Processing Disorder | Sensory Disorder | Infant Development | Development Delay | Infant, Very Low Birth Weight | Infant Asphyxia | Motor DelayTurkey