Evaluating the Non-Inferiority of Airmod to Capnostream™35

NCT05263791 | Completed Results DMC

• 1 other identifier: 21CT020be
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

Respiratory Rate

Keywords

Airmod; Respiratory Rate; Deep learning; Auscultation sound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  up to 4 hours

• Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots)

  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

  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

  up to 4 hours

• Safety and Usability of Airmod.

  In the study , All participants spend less than 30 min writing thesis questionnaire.

Study Arms (1)

Airmod

EXPERIMENTAL

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

Interventions

Airmod DEVICE

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.

Airmod

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heroic Faith Medical Science Co., Ltd.: lead
• Elite BioMedical Consulting Inc.: collaborator

Study Sites (3)

En Chu Kong Hospital

New Taipei City, 237, Taiwan

Location

MacKay Memorial Hospital

Taipei, 10491, Taiwan

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 25025587 BACKGROUND

• 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.

  PMID: 34197556 BACKGROUND

Results Point of Contact

• Title: Chien-Chung Huang
• Organization: MacKay Memorial Hospital

titanh@gmail.com

02-25433535

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 3, 2022
• Study Start: December 16, 2021
• Primary Completion: September 27, 2022
• Study Completion: September 1, 2023
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)