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

Yonsei University

Status: Enrolling

Conditions: Asthma; Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis

Treatments: Device: HiCardi+

Study type: Interventional

Funder types: Other

Identifiers

NCT05863091

1-2022-0055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

211 participants in 2 patient groups

A group of patients undergoing pulmonary function tests

Experimental group

Description:

Patients undergoing pulmonary function tests with spontaneous breathing

Treatment:

Device: HiCardi+

Device: HiCardi+

A group of patients on ventilators in an intensive care unit

Experimental group

Description:

Among patients who are on a ventilator, those on the Richmond agitation sedation scale -4 to -5 and who do not breathe spontaneously

Treatment:

Device: HiCardi+

Device: HiCardi+