Patients in Surgical Intensive CareNCT04261062

Validity Test of Wearable Continuous Blood Pressure Measuring System

An observational study of Patients in Surgical Intensive Care, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

1. Purpose of Research For the feasibility test of a wearable blood pressure measuring device, biometric data of patients in surgical intensive care is simultaneously obtained and stored from the device and a patient monitor. 2. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients in Surgical Intensive Care
How many people: 220 participants
Where: 1 siteSouth Korea
Study dates: 7 May 2020to Jan 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients in surgical intensive care

Who may be able to join

Adult patient in surgical intensive care of Severance Hospital
Voluntarily agreed to participate the research and not included to the exclusion criteria

Who cannot join

Patient with occlusive peripheral arterial disease
Patient with cardiovascular disease of serious arrhythmia except atrial fibrillation
Patient administered high-dose of pressor agent over 15 mcg/min
Patient who is not available for measurement of invasive arterial blood pressure
Patient who is not available to wear an wearable device on the wrist
Pregnant woman, minor

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine
Seoul
Jeongmin Kim, 82-2-2227-3569, anesjeongmin@yuhs.ac
Jeongmin Kim
Recruiting

Other trials in South Korea

About this study

Purpose of Research For the feasibility test of a wearable blood pressure measuring device, biometric data of patients in surgical intensive care is simultaneously obtained and stored from the device and a patient monitor.
Overview of Research Design This research is simply to obtain and store the data: 1) invasive arterial blood pressure measured with a patient monitor from one wrist, and 2) multi-wavelength photoplethysmography and pressure signal measured with the developed wearable device from the other wrist.
Medical Device for Clinical Trial Patient monitor (IntelliVue MX700, Philips, NED) and wearable blood pressure measuring device
Target Recruiting Number of Participants Considering the expected patient number in intensive care and 10% dropout rate during the research period, the target recurring number of participants is 220.
Criteria of Participant Inclusion
Adult patient in surgical intensive care of Severance Hospital
Voluntarily agreed to participate the research and not included to the exclusion criteria
Criteria of Participant Exclusion
Patient with occlusive peripheral arterial disease
Patient with cardiovascular disease of serious arrhythmia except atrial fibrillation
Patient administered high-dose of pressor agent over 15 mcg/min
Patient who is not available for measurement of invasive arterial blood pressure
Patient who is not available to wear an wearable device on the wrist
Pregnant woman, minor
Evaluation Parameter
Systolic and diastolic blood pressure, which extracted in mmHg unit from the continuous blood pressure output of patient monitor.
Blood pressure, which estimated by the signal analysis of multi-wavelength photoplethysmography and pressure signal measured with the wearable device.
Data Analysis and Statistical Methods
From the multi-wavelength photoplethysmography and multi-channel pressure signal measured, continuous blood pressure will be estimated through the hemodynamic model and machine learning model.
For the machine learning model, the data obtained will be divided into the training data and evaluation data, with the ratio of 80% and 20%.
In order to evaluate the accuracy of the estimated blood pressure, the invasive arterial blood pressure will be considered as the reference blood pressure. Between the estimated blood pressure and the reference blood pressure, the correlation and root mean square error (RMSE) will be calculated.

Read the detailed description

Recruit participants.
Explain the research purpose and details, and then have the participant sign the consent form.
Before starting the measurement, gather the participant's information such as age, length, and weight.
Measure noninvasive blood pressure in both arms. Compared to the blood pressure in the arm where inserted a catheter, confirm if difference of systolic or diastolic blood pressure in the other side of arm is not more than 10%.
Wear the wearable device on the opposite wrist from the catheter-inserted.
For 10 minutes, simultaneously obtain the data: 1) invasive arterial blood pressure measured with a patient monitor, and 2) multi-wavelength photoplethysmography and pressure signal measured with the developed wearable device.
For accuracy of data acquisition, repeat twice the procedure 5-7 by performing it in the morning and in the afternoon with the 5 hours interval.

Conditions: Patients in Surgical Intensive Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04261062
Study group	Role	What they receive
Subject		Patients in surgical intensive unit

What is being measured

The primary outcome is the main question the study is designed to answer.

Title quality of pulsewave
Measured: 2 years

Secondary outcomes (1)

User Comfortability
Abnormal symptoms or discomforts reported in wearing device
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 2020Jan 2022

First posted7 Feb 2020
Study start7 May 2020
Primary completionJan 2022 (estimated)
Study completionJan 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Patients in Surgical Intensive CareStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe 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: Other
Time perspective: Other
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04261062
Sponsor's protocol ID: 1-2019-0080
Status last verified: Jul 2020
First submitted: 6 Feb 2020
Last updated: 23 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hughes DJ, Babbs CF, Geddes LA, Bourland JD. Measurements of Young's modulus of elasticity of the canine aorta with ultrasound. Ultrason Imaging. 1979 Oct;1(4):356-67. doi: 10.1177/016173467900100406. No abstract available.
PubMed 575833
Liu J, Yan BP, Dai WX, Ding XR, Zhang YT, Zhao N. Multi-wavelength photoplethysmography method for skin arterial pulse extraction. Biomed Opt Express. 2016 Sep 27;7(10):4313-4326. doi: 10.1364/BOE.7.004313. eCollection 2016 Oct 1.
PubMed 27867733
Guanqun Zhang, Cottrell AC, Henry IC, McCombie DB. Assessment of pre-ejection period in ambulatory subjects using seismocardiogram in a wearable blood pressure monitor. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3386-3389. doi: 10.1109/EMBC.2016.7591454.
PubMed 28269030
Corino VD, Lombardi F, Mainardi LT. Blood pressure variability in patients with atrial fibrillation. Auton Neurosci. 2014 Oct;185:129-33. doi: 10.1016/j.autneu.2014.08.002. Epub 2014 Aug 17.
PubMed 25183309
Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.
PubMed 16052125
Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.
PubMed 18305265

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Patients in Surgical Intensive Care trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validity Test of Wearable Continuous Blood Pressure Measuring System
ClinicalTrials.gov ID: NCT04261062
Acronym / sponsor ID: 1-2019-0080
Conditions: Patients in Surgical Intensive Care
Study type: Observational
Recruitment status: Unknown status
Enrolment: 220 participants (estimated)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 7 May 2020 (actual)
Primary completion: Jan 2022 (estimated)
Study completion: Jan 2022 (estimated)
First posted: 7 Feb 2020 (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.

Purpose of Research For the feasibility test of a wearable blood pressure measuring device, biometric data of patients in surgical intensive care is simultaneously obtained and stored from the device and a patient monitor.
Overview of Research Design This research is simply to obtain and store the data: 1) invasive arterial blood pressure measured with a patient monitor from one wrist, and 2) multi-wavelength photoplethysmography and pressure signal measured with the developed wearable device from the other wrist.
Medical Device for Clinical Trial Patient monitor (IntelliVue MX700, Philips, NED) and wearable blood pressure measuring device
Target Recruiting Number of Participants Considering the expected patient number in intensive care and 10% dropout rate during the research period, the target recurring number of participants is 220.
Criteria of Participant Inclusion
Adult patient in surgical intensive care of Severance Hospital
Voluntarily agreed to participate the research and not included to the exclusion criteria
Criteria of Participant Exclusion
Patient with occlusive peripheral arterial disease
Patient with cardiovascular disease of serious arrhythmia except atrial fibrillation
Patient administered high-dose of pressor agent over 15 mcg/min
Patient who is not available for measurement of invasive arterial blood pressure
Patient who is not available to wear an wearable device on the wrist
Pregnant woman, minor
Evaluation Parameter
Systolic and diastolic blood pressure, which extracted in mmHg unit from the continuous blood pressure output of patient monitor.
Blood pressure, which estimated by the signal analysis of multi-wavelength photoplethysmography and pressure signal measured with the wearable device.
Data Analysis and Statistical Methods
From the multi-wavelength photoplethysmography and multi-channel pressure signal measured, continuous blood pressure will be estimated through the hemodynamic model and machine learning model.
For the machine learning model, the data obtained will be divided into the training data and evaluation data, with the ratio of 80% and 20%.
In order to evaluate the accuracy of the estimated blood pressure, the invasive arterial blood pressure will be considered as the reference blood pressure. Between the estimated blood pressure and the reference blood pressure, the correlation and root mean square error (RMSE) will be calculated.

Detailed description

Recruit participants.
Explain the research purpose and details, and then have the participant sign the consent form.
Before starting the measurement, gather the participant's information such as age, length, and weight.
Measure noninvasive blood pressure in both arms. Compared to the blood pressure in the arm where inserted a catheter, confirm if difference of systolic or diastolic blood pressure in the other side of arm is not more than 10%.
Wear the wearable device on the opposite wrist from the catheter-inserted.
For 10 minutes, simultaneously obtain the data: 1) invasive arterial blood pressure measured with a patient monitor, and 2) multi-wavelength photoplethysmography and pressure signal measured with the developed wearable device.
For accuracy of data acquisition, repeat twice the procedure 5-7 by performing it in the morning and in the afternoon with the 5 hours interval.

Study design

Observational model: Other
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Subject	–	–Patients in surgical intensive unit

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients in surgical intensive care

Key inclusion criteria (2 listed)

Adult patient in surgical intensive care of Severance Hospital
Voluntarily agreed to participate the research and not included to the exclusion criteria

Key exclusion criteria (6 listed)

Patient with occlusive peripheral arterial disease
Patient with cardiovascular disease of serious arrhythmia except atrial fibrillation
Patient administered high-dose of pressor agent over 15 mcg/min
Patient who is not available for measurement of invasive arterial blood pressure
Patient who is not available to wear an wearable device on the wrist

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Title quality of pulsewave
Time frame: 2 years

1 secondary outcome

User Comfortability
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
Background: PubMed 575833Hughes DJ, Babbs CF, Geddes LA, Bourland JD. Measurements of Young's modulus of elasticity of the canine aorta with ultrasound. Ultrason Imaging. 1979 Oct;1(4):356-67. doi: 10.1177/016173467900100406. No abstract available.
Background: PubMed 27867733Liu J, Yan BP, Dai WX, Ding XR, Zhang YT, Zhao N. Multi-wavelength photoplethysmography method for skin arterial pulse extraction. Biomed Opt Express. 2016 Sep 27;7(10):4313-4326. doi: 10.1364/BOE.7.004313. eCollection 2016 Oct 1.
Background: PubMed 28269030Guanqun Zhang, Cottrell AC, Henry IC, McCombie DB. Assessment of pre-ejection period in ambulatory subjects using seismocardiogram in a wearable blood pressure monitor. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3386-3389. doi: 10.1109/EMBC.2016.7591454.
Background: PubMed 25183309Corino VD, Lombardi F, Mainardi LT. Blood pressure variability in patients with atrial fibrillation. Auton Neurosci. 2014 Oct;185:129-33. doi: 10.1016/j.autneu.2014.08.002. Epub 2014 Aug 17.
Background: PubMed 16052125Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.
Background: PubMed 18305265Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.
Individual participant dataSharing planned: No

Related trials for Patients in Surgical Intensive Care

Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Active, not recruiting
BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients
Fluid and Electrolyte Imbalance, Anesthesia
Active, not recruiting
A Communication Tool to Improve Communication in the ICU
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Recruiting
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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.

Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine

Seoul, South Korea

82-2-2227-3569

anesjeongmin@yuhs.ac

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 Patients in Surgical Intensive Care, run by Yonsei University 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 6 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 Jul 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Title quality of pulsewave (time frame: 2 years). 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 NCT04261062, which also lists 6 linked publications.

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 Jul 2020.