Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863091
Status:
RECRUITING
Last Update Posted:
2023-05-17
First Post:
2023-04-19
Brief Title:
Respiratory Rate Validation Study - HiCardi Wearable Patch Device Mezoo Co Ltd
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 82 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
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 82 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None