Pulmonary Disease, Chronic ObstructiveNCT05863091
Respiratory Rate Validation Study - HiCardi+ Wearable Patch Device, Mezoo Co., Ltd.
A study testing HiCardi+ in people with Pulmonary Disease, Chronic Obstructive and Idiopathic Pulmonary Fibrosis, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the accuracy of respiratory and breathing patterns generated through impedance changes generated by a patch-type electrocardiogram device (HiCardi+ wearable patch device, Mezoo Co., Ltd.), targeting patients undergoing pulmonary function testing and ventilator application. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Asthma
- What is being tested?
- HiCardi+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2023to Jun 2023
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 19 and older
Who cannot join
- patients under the age of 19
- patients cannot apply the patch-type electrocardiogram device due to physical defects or contact allergic reactions
- patients do not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
Kyung Soo Chung, (+82)-10-7514-0053, chungks@yuhs.ac
About this study
Official title: Respiratory Rate Validation Study With Accuracy Analysis of Respiratory and Breathing Pattern Extracted by Impedance Change of Patch-type Electrocardiogram Device (HiCardi+ Wearable Patch Device, Mezoo Co., Ltd.)
The purpose of this study is to analyze the accuracy of respiratory and breathing patterns generated through impedance changes generated by a patch-type electrocardiogram device (HiCardi+ wearable patch device, Mezoo Co., Ltd.), targeting patients undergoing pulmonary function testing and ventilator application.
Read the detailed description
Subjects The target number of participants for this study is 211, consisting of 181 patients undergoing pulmonary function testing and 30 patients using a ventilator.
- Spontaneous breathing subjects (181 patients): Assuming that a pulmonary function testing examiner with spontaneous breathing would examine about 50 patients per day, a total of 181 subjects will be targeted, taking into consideration the possibility of refusals.
- Non-Spontaneous breathing subjects (30 patients): In addition, in the case of patients with a Richmond Agitation Sedation Scale of -4 to -5 who use a ventilator and do not have spontaneous breathing, the final 30 subjects will be conducted for the purpose of data collection for about 6 hours.
Focus of the study The tidal volume and respiratory amplitude will be analyzed in detail through pulmonary function tests, and the respiratory rate will be analyzed through ventilator data.
Study method The study method is as follows: In the pulmonary function testing room, consent will be obtained from patients undergoing pulmonary function testing, and a patch-type electrocardiogram device will be attached before the test is conducted. The records of the ECG patch generated during the approximately 30-minute pulmonary function test and the results of the pulmonary function test will be acquired. Based on the impedance obtained from the patch-type electrocardiogram, the pulmonary function test results are extracted as the reference data related to the respiratory pattern. Correlation analysis is performed on the tidal volume and respiratory amplitude obtained through this comparison. Additionally, Bland-Altman analysis is conducted on the validation set, which is divided into an 8:2 training set and validation set, for the algorithm that predicts tidal volume and respiratory amplitude.
For patients with RASS -4 to -5 who are on a ventilator, the patch-type electrocardiogram device is attached for about 6 hours after the consent of the patient caregiver, and the data generated from the ECG patch and the ventilator are compared and analyzed. Based on the impedance obtained from the patch-type electrocardiogram, the data from the ventilator will be used as reference data related to respiratory rate. Mean Difference (MD), Standard Deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated through correlation analysis and Bland-Altman analysis on the obtained respiratory rate.
- Being tested
- HiCardi+
- Keywords
- Pulmonary Function Testing(PFT), Ventilator, Patch-type electrocardiogram device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiCardi+Device
A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests.
HiCardi+Device
A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| A group of patients undergoing pulmonary function tests | Experimental | Patients undergoing pulmonary function tests with spontaneous breathing Receives: Device: HiCardi+ |
| A group of patients on ventilators in an intensive care unit | Experimental | Among patients who are on a ventilator, those on the Richmond agitation sedation scale -4 to -5 and who do not breathe spontaneously Receives: Device: HiCardi+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate measured by pulmonary function test
The respiratory rate will be analyzed for correlation and Bland-Altman analysis using continuous variables generated from pulmonary function testing, ventilator information, and patch-type ECG device. Mean difference (MD), standard deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated.
Measured: During the pulmonary function test (about 30 minutes)
Respiratory rate measured by ventilator
The respiratory rate will be analyzed for correlation and Bland-Altman analysis using continuous variables generated from pulmonary function testing, ventilator information, and patch-type ECG device. Mean difference (MD), standard deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated.
Measured: about 6 hours
Respiratory rate measured by patch-type electrocardiogram device
The respiratory rate will be analyzed for correlation and Bland-Altman analysis using continuous variables generated from pulmonary function testing, ventilator information, and patch-type ECG device. Mean difference (MD), standard deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated.
Measured: up to 6 hours
Secondary outcomes (2)
Tidal volume measured by pulmonary function test, ventilator, and patch-type electrocardiogram device
For tidal volume and respiratory amplitude, correlation analysis is performed on continuous variables generated from pulmonary function tests, ventilator information, and a patch-type electrocardiogram measuring device. Additionally, the algorithm for predicting respiratory volume and respiratory amplitude is divided into a training set and a validation set in an 8:2 ratio, and Bland-Altman analysis is performed on the validation set.
Measured: -Pulmonary function test: During the pulmonary function test (about 30 minutes) -Ventilator application: about 6 hours
respiratory amplitude measured by pulmonary function test, ventilator, and patch-type electrocardiogram device
For tidal volume and respiratory amplitude, correlation analysis is performed on continuous variables generated from pulmonary function tests, ventilator information, and a patch-type electrocardiogram measuring device. Additionally, the algorithm for predicting respiratory volume and respiratory amplitude is divided into a training set and a validation set in an 8:2 ratio, and Bland-Altman analysis is performed on the validation set.
Measured: -Pulmonary function test: During the pulmonary function test (takes about 30 minutes) -Ventilator application: about 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start9 Mar 2023
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863091
- Sponsor's protocol ID
- 1-2022-0055
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Validation Study With Accuracy Analysis of Respiratory and Breathing Pattern Extracted by Impedance Change of Patch-type Electrocardiogram Device (HiCardi+ Wearable Patch Device, Mezoo Co., Ltd.)
- ClinicalTrials.gov ID
- NCT05863091
- Acronym / sponsor ID
- 1-2022-0055
- Keywords
- Pulmonary Function Testing(PFT), Ventilator, Patch-type electrocardiogram device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 May 2023 (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 purpose of this study is to analyze the accuracy of respiratory and breathing patterns generated through impedance changes generated by a patch-type electrocardiogram device (HiCardi+ wearable patch device, Mezoo Co., Ltd.), targeting patients undergoing pulmonary function testing and ventilator application.
Detailed description
Subjects The target number of participants for this study is 211, consisting of 181 patients undergoing pulmonary function testing and 30 patients using a ventilator.
- Spontaneous breathing subjects (181 patients): Assuming that a pulmonary function testing examiner with spontaneous breathing would examine about 50 patients per day, a total of 181 subjects will be targeted, taking into consideration the possibility of refusals.
- Non-Spontaneous breathing subjects (30 patients): In addition, in the case of patients with a Richmond Agitation Sedation Scale of -4 to -5 who use a ventilator and do not have spontaneous breathing, the final 30 subjects will be conducted for the purpose of data collection for about 6 hours.
Focus of the study The tidal volume and respiratory amplitude will be analyzed in detail through pulmonary function tests, and the respiratory rate will be analyzed through ventilator data.
Study method The study method is as follows: In the pulmonary function testing room, consent will be obtained from patients undergoing pulmonary function testing, and a patch-type electrocardiogram device will be attached before the test is conducted. The records of the ECG patch generated during the approximately 30-minute pulmonary function test and the results of the pulmonary function test will be acquired. Based on the impedance obtained from the patch-type electrocardiogram, the pulmonary function test results are extracted as the reference data related to the respiratory pattern. Correlation analysis is performed on the tidal volume and respiratory amplitude obtained through this comparison. Additionally, Bland-Altman analysis is conducted on the validation set, which is divided into an 8:2 training set and validation set, for the algorithm that predicts tidal volume and respiratory amplitude.
For patients with RASS -4 to -5 who are on a ventilator, the patch-type electrocardiogram device is attached for about 6 hours after the consent of the patient caregiver, and the data generated from the ECG patch and the ventilator are compared and analyzed. Based on the impedance obtained from the patch-type electrocardiogram, the data from the ventilator will be used as reference data related to respiratory rate. Mean Difference (MD), Standard Deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated through correlation analysis and Bland-Altman analysis on the obtained respiratory rate.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group of patients undergoing pulmonary function tests | Experimental | Device: HiCardi+Patients undergoing pulmonary function tests with spontaneous breathing |
| A group of patients on ventilators in an intensive care unit | Experimental | Device: HiCardi+Among patients who are on a ventilator, those on the Richmond agitation sedation scale -4 to -5 and who do not breathe spontaneously |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 19 and older
Key exclusion criteria (3 listed)
- patients under the age of 19
- patients cannot apply the patch-type electrocardiogram device due to physical defects or contact allergic reactions
- patients do not consent to participate in the study
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 |
|---|---|---|
| HiCardi+A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests. | Device | A group of patients undergoing pulmonary function tests |
| HiCardi+A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit. | Device | A group of patients on ventilators in an intensive care unit |
Primary outcome
Respiratory rate measured by pulmonary function test
Time frame: During the pulmonary function test (about 30 minutes)
The respiratory rate will be analyzed for correlation and Bland-Altman analysis using continuous variables generated from pulmonary function testing, ventilator information, and patch-type ECG device. Mean difference (MD), standard deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated.
Respiratory rate measured by ventilator
Time frame: about 6 hours
The respiratory rate will be analyzed for correlation and Bland-Altman analysis using continuous variables generated from pulmonary function testing, ventilator information, and patch-type ECG device. Mean difference (MD), standard deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated.
Respiratory rate measured by patch-type electrocardiogram device
Time frame: up to 6 hours
The respiratory rate will be analyzed for correlation and Bland-Altman analysis using continuous variables generated from pulmonary function testing, ventilator information, and patch-type ECG device. Mean difference (MD), standard deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated.
2 secondary outcomes
Tidal volume measured by pulmonary function test, ventilator, and patch-type electrocardiogram device
Time frame: -Pulmonary function test: During the pulmonary function test (about 30 minutes) -Ventilator application: about 6 hours
respiratory amplitude measured by pulmonary function test, ventilator, and patch-type electrocardiogram device
Time frame: -Pulmonary function test: During the pulmonary function test (takes about 30 minutes) -Ventilator application: about 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiCardi+ in people with Pulmonary Disease, Chronic Obstructive and Idiopathic Pulmonary Fibrosis, 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 1 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 17 May 2023. 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 Kyung Soo Chung ((+82)-10-7514-0053, CHUNGKS@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate measured by pulmonary function test (time frame: During the pulmonary function test (about 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2023.