Evaluation the Non-Inferiority of Airmod to Capnostream™35

Study Overview
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Brief Summary
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This study is a multi-center clinical study of non-invasive medical device in Taiwan. After pre-anaesthesia evaluation, subjects who are suitable for intravenous general anesthesia (IVG) and age 20 years or older will be recruited in this clinical study. 150 subjects will be recruited at this site. The total 300 subjects will be recruited in other clinical centers at En Chu Kong Hospital simultaneously and Cathay General Hospital and Doctor Huang, Chien-Chung of the Anesthesia Department of MacKay Memorial Hospital is the PI of this study. The objective of this study is to evaluate the respiratory rate monitoring performance of Airmod respiratory monitoring assistant software, used with the AccurSound Electronic Stethoscope AS-101 (TFDA Certificate No. 007347) compared to the Medtronic Capnostream™35 Portable Respiratory Monitor (TFDA Certificate No. 032283), hereinafter referred to as comparison method, is non-inferiority than the comparison method. In addition, in order to improve the quality of patient care and ensure safety, this study will also synchronously record the breathing sounds from the  AccurSound Electronic Stethoscope  during the study with the respiratory symptoms of the comparison method, such as: asthma sounds, phlegm sounds, airway infiltration, water accumulation, obstructive sounds, respiratory arrest and respiratory tract edema, and analyze the vital signs for further improvement in the future. Primary Objective: To evaluate accuracy and performance of respiratory rate (RR) measurement from Airmod compared to the comparison method. The primary objective is to establish the non-inferiority. Secondary Objectives: 1. To assess the accuracy of respiratory ate measurement by Airmod comparison with manual-scored auscultation sound during the less sensitive period of Capnography on the comparison method. 2. To measure the agreement between AirRR* and ManCRR*. 3. To evaluate the response time of the first breath detection followed by administration of jaw thrust during the apnea period. The 3rd secondary objective is to compare the response time of Airmod versus the comparison method. 4. To compare the influence of subjects to variated breath rates on respiratory rate monitoring in bpm as measured by Airmod, manual-scored and the Capnostream™35. 5. To evaluate the safety and usability of Airmod. * AirRR Airmod-scored auscultation sound generated from AS-101 * ManCRR Manual-scored Capnography (ManCRR)originated from CapnostreamTM35 (K150272, Medtronic)

Official Title
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Evaluation the Non-Inferiority of Airmod to Capnostream™35 on Respiratory Rate Monitoring and User Experience Clinical Evaluation

Conditions
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Respiratory Rate

Intervention / Treatment
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* Device: Airmod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female with at least 20 years of age. Fit for intravenous general anesthesia (IVG) as assessed by pre-anesthesia evaluation. Exclusion Criteria: Presence of neck pain or injuries. Under the use of high-flow nasal cannula ventilation. Patients with advanced airway management equipment. (For instance, Supraglottic airway device, LMA, Endotracheal tube.) Some equipment, such as High Flow Nasal Cannula (HFNC), CPAP, suction machine, could continually make noise in the patient's airway, affecting auscultation and RR measurement. Unable to wear Airmod and Capnostream™35 device related accessories at the investigator's discretion. As a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support. Unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airmod<br>The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. | Device: Airmod<br>* Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | To evaluate accuracy and performance of respiratory rate (RR) measurement from Airmod compared to the comparison method. The primary objective is to establish the non-inferiority. The study time frame for the primary outcome is the perioperative period. The perioperative period of a procedure sedation patient includes preparation, intraoperative period, interoperation transportation, and postanesthesia care unit stay and discharge. A patient will discharge and leave the study once discharged from the PACU. We intend to report the primary endpoint in the perioperative period as a single target and perform subgroup analysis for each stage in the future study. | up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Accuracy of Airmod in reference device less sensitivity period | To assess the accuracy of respiratory rate measurement by Airmod in comparison with manual-scored auscultation sound during the less sensitive period of Capnography on Capnostream™35. | up to 4 hours | 
| Agreement between airmod and reference device | To measure the agreement of AirRR and ManCRR on concordance correlation coefficient, and on their mean and bias by Bland-Altman analysis. Manual-scored auscultation sound (ManARR) originated from Airmod Airmod-scored auscultation sound (AirRR) generated from Airmod | up to 4 hours | 
| Responsive time of Airmod and reference device | To evaluate the response time of the first breath detection followed by administration of jaw thrust during the apnea period. The objective is to compare the response time of Airmod versus Capnography by using Use paired t-test to compare the response time of Airmod versus Capnography on Capnostream™35 after administration of jaw thrust. In the target of p<0.05 indicates significance. | up to 4 hours | 
| Effectiveness study | Mean deviation > -3 Breath Per Minutes (BPM), Airmod (SaMD) to Manual Scored Capnography (Reference) The software calculates respiratory rate values via the sensors (digital stethoscope recording with Airmod / end-tidal CO2 recording with Capnostream™35) with a mean deviation of greater than the margin breath per minute relative to the manual scored capnography. The mean deviation values estimate the mean difference in simultaneous estimates of respiratory rate from devices under test and the reference device. Margin : M1 (-3BPM) represents the substantial equivalence. M2 (-2BPM) represents the largest clinically acceptable difference. We propose two step endpoint, the -3 stands for non-inferiority margin, and -2 stands for largest clinically acceptable difference. | up to 4 hours | 
| Safety and usability of Airmod. | Any adverse events and comments on usability will be counted and summarized using standard summary measures. | Through study completion, up to 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airmod, Respiratory Rate, Deep learning, Auscultation sound