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| Name | Class |
|---|---|
| Elite BioMedical Consulting Inc. | INDUSTRY |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| En Chu Kong Hospital | New Taipei City | 237 | Taiwan | |||
| MacKay Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25025587 | Background | 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. | |
| 34197556 | Background |
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The candidate was invited during their pre-anesthesia appointment and provided with an informed consent form, which explained the details, benefits, and risks of participating in the study. Research staff simultaneously reviewed the candidate's eligibility. The candidate was given at least one day to review and sign the informed consent form before proceeding with the procedures and being formally enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Airmod | The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. 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. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Airmod | The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | breaths per minute | up to 4 hours | minute | minute |
|
up to 4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Airmod | The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chien-Chung Huang | MacKay Memorial Hospital | 02-25433535 | 3009 | titanh@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2021 | Jan 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2022 | Jan 8, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 27, 2021 | Feb 20, 2024 | ICF_002.pdf |
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| 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. |
| Taipei |
| 10491 |
| Taiwan |
| Cathay General Hospital | Taipei | 106 | Taiwan |
| 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Neck circumference | Mean | Standard Deviation | cm |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Charlson Comorbidity Scale | In the demographic section, the Charlson Comorbidity Index (CCI) was calculated based on the patients' medical history as recorded in their health records, with most conditions being diagnosed by a physician. The index was adjusted for age, assigning 1 point for patients aged 50-59, 2 points for those aged 60-69, 3 points for those aged 70-79, and 4 points for those aged 80 or older. A higher CCI score indicates a worse prognosis and an increased risk of mortality. | Count of Participants | Participants |
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| American Society of Anesthesiologists' Physical Status Classification | The ASA score was referal to "https://www.asahq.org/standards-and-practice-parameters/statement-on-asa-physical-status-classification-system" In brief, ASA I stands for A normal healthy patient, ASA II stands for A patient with mild systemic disease, ASA III stands for A patient with severe systemic disease, ASA IV stands for A patient with severe systemic disease that is a constant threat to life, ASA V stands for A moribund patient who is not expected to survive without the operation, ASA VI stands for A declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
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| Secondary | 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) | Posted | Mean | Standard Deviation | breaths per minute | up to 4 hours | minute | minute |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | breaths per minute | up to 4 hours | breaths per minute | breaths per minute |
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| Secondary | 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). | In this analysis, we investigated the response time of the first breath detection followed by the administration of a jaw thrust maneuver during the apnea period. As part of the study's third secondary objective, we aimed to compare the response time between the Airmod device and Capnography. | Posted | Mean | Standard Deviation | sec | up to 4 hours | event | event |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | breaths per minute | up to 4 hours | breaths per minute | breaths per minute |
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| Secondary | 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. | airmod operator | Posted | Number | participants | In the study , All participants spend less than 30 min writing thesis questionnaire. |
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| 0 |
| 255 |
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| 255 |
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| 255 |
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| Were you able to record the breath sound ? (Yes:1, No:0) |
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| Were you able to key in patient's info? (Yes:1, No:0) |
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| Were you able to adjust the sound playback mode? (Yes:1, No:0) |
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| Were you able to stop the breath sound recording ? (Yes:1, No:0) |
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| Were you able to adjust settings? (Yes:1, No:0) |
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| Were you able to review patient's breath sound recording? (Yes:1, No:0) |
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| Overall, were you able to use Airmod APP? (Yes:1, No:0) |
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