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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HiCardi+
HiCardi+
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Function Testing(PFT), Ventilator, Patch-type electrocardiogram device

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A group of patients undergoing pulmonary function tests

A group of patients on ventilators in an intensive care unit

Arm Description

Patients undergoing pulmonary function tests with spontaneous breathing

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 19, 2023
Last Updated
May 8, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05863091
Brief Title
Respiratory Rate Validation Study - HiCardi+ Wearable Patch Device, Mezoo Co., Ltd.
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.)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Asthma
Keywords
Pulmonary Function Testing(PFT), Ventilator, Patch-type electrocardiogram device

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
211 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group of patients undergoing pulmonary function tests
Arm Type
Experimental
Arm Description
Patients undergoing pulmonary function tests with spontaneous breathing
Arm Title
A group of patients on ventilators in an intensive care unit
Arm Type
Experimental
Arm Description
Among patients who are on a ventilator, those on the Richmond agitation sedation scale -4 to -5 and who do not breathe spontaneously
Intervention Type
Device
Intervention Name(s)
HiCardi+
Intervention Description
A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests.
Intervention Type
Device
Intervention Name(s)
HiCardi+
Intervention Description
A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit.
Primary Outcome Measure Information:
Title
Respiratory rate measured by pulmonary function test
Description
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.
Time Frame
During the pulmonary function test (about 30 minutes)
Title
Respiratory rate measured by ventilator
Description
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.
Time Frame
about 6 hours
Title
Respiratory rate measured by patch-type electrocardiogram device
Description
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.
Time Frame
up to 6 hours
Secondary Outcome Measure Information:
Title
Tidal volume measured by pulmonary function test, ventilator, and patch-type electrocardiogram device
Description
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.
Time Frame
-Pulmonary function test: During the pulmonary function test (about 30 minutes) -Ventilator application: about 6 hours
Title
respiratory amplitude measured by pulmonary function test, ventilator, and patch-type electrocardiogram device
Description
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.
Time Frame
-Pulmonary function test: During the pulmonary function test (takes about 30 minutes) -Ventilator application: about 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Soo Chung
Phone
(+82)-10-7514-0053
Email
CHUNGKS@yuhs.ac
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung Soo Chung
Phone
(+82)-10-7514-0053
Email
chungks@yuhs.ac

12. IPD Sharing Statement

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

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