Evaluating the Non-Inferiority of Airmod to Capnostream™35

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

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)

Study Overview

• Status: Completed
• Conditions: Respiratory Rate
• Intervention / Treatment: Device: Airmod

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 237
    • En Chu Kong Hospital
  • Taipei City, Taiwan, 106
    • Cathay General Hospital
  • Taipei City, Taiwan, 10491
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female with at least 20 years of age.
4. Fit for intravenous general anesthesia (IVG) as assessed by pre-anesthesia evaluation.

Exclusion Criteria:

1. Presence of neck pain or injuries.
2. 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.
3. Unable to wear Airmod and Capnostream™35 device related accessories at the investigator's discretion.
4. 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.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airmod; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of the Difference Between airRR and mancRR	The mean difference is based on the comparative pair (reference: mancRR - device under test: airRR) (unit: BPM) The measurement of airRR (airmod recorded breathing rate per minute: BPM ) (minimal: 4 BPM, maximal: 35BPM) The measurement of mancRR (manual scored capnography breathing rate per minute: BPM) (minimal : 0 BPM, maximal 39BPM)	up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis 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	The mean difference is based on the comparative pair (reference: acoRR - device under test: airRR) (unit: BPM) The measurement of airRR (airmod recorded breathing rate per minute: BPM ) (minimal: 4 BPM, maximal: 35BPM) The measurement of acoRR (manual scored auscultation sound breathing rate per minute: BPM) (minimal : 0 BPM, maximal 60BPM)	up to 4 hours
Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots)	The Bland-Altman plot and limits of agreement compare the following respiratory rates, all measured in BPM: airRR (Airmod recorded respiratory rate), capRR (capnography recorded respiratory rate), and acoRR (manually scored auscultation respiratory rate) against mancRR (manually scored capnography respiratory rate).	up to 4 hours
Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period	We examined the response time for detecting the first breath after administering a jaw thrust maneuver during an apnea period. The results included the latency of the Airmod breathing response (measured in seconds), the latency of capnography (measured in seconds), and the difference in latency between Airmod and capnography (measured in seconds).	up to 4 hours
Analysis to Compare the Influence of Subjects to Variated Breath Rates on Respiratory Rate Monitoring in Bpm as Measured by Airmod, Manual-scored and Capnostream™35	The mean difference is based on the comparative pair (reference: mancRR - device under test: airRR) (unit: BPM) The measurement of airRR (airmod recorded breathing rate per minute: BPM ) (minimal: 4 BPM, maximal: 35BPM) The measurement of mancRR (manual scored capnography breathing rate per minute: BPM) (minimal : 0 BPM, maximal 39BPM).	up to 4 hours
Safety and Usability of Airmod.	Questionnaire response from research staff, each question score 0 or 1 by candidate, the result stands for successful numbers over all candidates in specific question.	In the study , All participants spend less than 30 min writing thesis questionnaire.

Collaborators and Investigators

• Sponsor: Heroic Faith Medical Science Co., Ltd.
• Collaborators: Elite BioMedical Consulting Inc

Publications and helpful links

General Publications

• Atkins JH, Mandel JE. Performance of Masimo rainbow acoustic monitoring for tracking changing respiratory rates under laryngeal mask airway general anesthesia for surgical procedures in the operating room: a prospective observational study. Anesth Analg. 2014 Dec;119(6):1307-14. doi: 10.1213/ANE.0000000000000362.
• Hsu FS, Huang SR, Huang CW, Huang CJ, Cheng YR, Chen CC, Hsiao J, Chen CW, Chen LC, Lai YC, Hsu BF, Lin NJ, Tsai WL, Wu YL, Tseng TL, Tseng CT, Chen YT, Lai F. Benchmarking of eight recurrent neural network variants for breath phase and adventitious sound detection on a self-developed open-access lung sound database-HF_Lung_V1. PLoS One. 2021 Jul 1;16(7):e0254134. doi: 10.1371/journal.pone.0254134. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory Rate; Airmod; Deep learning; Auscultation sound
• Other Study ID Numbers: 21CT020be

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No