Evaluation the Non-Inferiority of Airmod to Capnostream™35

Respiratory Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263791
• Other study ID #: 21CT020be
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Heroic Faith Medical Science Co., Ltd.
• Contact: Yuan Ren Cheng, MS
• Phone: +886918062948
• Email: infie.cheng[@]heroic-faith.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

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.

Locations

Country	Name	City	State
Taiwan	En Chu Kong Hospital	New Taipei City
Taiwan	Cathay General Hospital	Taipei City
Taiwan	MacKay Memorial Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Heroic Faith Medical Science Co., Ltd.	Elite BioMedical Consulting Inc

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.