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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group of patients undergoing pulmonary function tests | Experimental | Patients undergoing pulmonary function tests with spontaneous breathing |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiCardi+ | Device | A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung Soo Chung | Contact | (+82)-10-7514-0053 | CHUNGKS@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D054990 | Idiopathic Pulmonary Fibrosis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| HiCardi+ | Device | A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit. |
|
| -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. | -Pulmonary function test: During the pulmonary function test (takes about 30 minutes) -Ventilator application: about 6 hours |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |