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

May 8, 2023 updated by: Yonsei University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kyung Soo Chung
  • Phone Number: (+82)-10-7514-0053
  • Email: chungks@yuhs.ac

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group of patients undergoing pulmonary function tests
Patients undergoing pulmonary function tests with spontaneous breathing
Device: HiCardi+
A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests.
Device: HiCardi+
A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit.
Experimental: A group of patients on ventilators in an intensive care unit
Among patients who are on a ventilator, those on the Richmond agitation sedation scale -4 to -5 and who do not breathe spontaneously
Device: HiCardi+
A patch-type electrocardiogram device is attached to a patient undergoing pulmonary function tests.
Device: HiCardi+
A patch-type electrocardiogram device is attached to a patient on a ventilator in an intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the pulmonary function test (about 30 minutes)
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.
about 6 hours
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.
up to 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2022-0055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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