Respiratory Rate Validation Study - HiCardi+ Wearable Patch Device, Mezoo Co., Ltd.

Asthma Clinical Trial

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.)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863091
• Other study ID #: 1-2022-0055
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: June 2023

Study information

• Verified date: May 2023
• Source: Yonsei University
• Contact: Kyung Soo Chung
• Phone: (+82)-10-7514-0053
• Email: CHUNGKS[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 211
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults 19 and older

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• Idiopathic Pulmonary Fibrosis
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Fibrosis

Intervention

Device:
• HiCardi+
A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests.
• HiCardi+
A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Secondary	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.	-Pulmonary function test: During the pulmonary function test (about 30 minutes) -Ventilator application: about 6 hours
Secondary	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