Respiratory Rate
Conditions
Keywords
Airmod, Respiratory Rate, Deep learning, Auscultation sound
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)
Interventions
DEVICEAirmod
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.
Sponsors
Elite BioMedical Consulting Inc.
Heroic Faith Medical Science Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test of the Difference Between airRR and mancRR | up to 4 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) | up to 4 hours | 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). |
| 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 | 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). |
| 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 | 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). |
| Safety and Usability of Airmod. | In the study , All participants spend less than 30 min writing thesis questionnaire. | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 255 |
| Total | 255 |
Baseline characteristics
| Characteristic | Airmod | — |
|---|---|---|
| Age, Continuous | 50.26 years STANDARD_DEVIATION 13.22 | — |
| American Society of Anesthesiologists' Physical Status Classification 1 | 17 Participants | — |
| American Society of Anesthesiologists' Physical Status Classification 2 | 207 Participants | — |
| American Society of Anesthesiologists' Physical Status Classification 3 | 31 Participants | — |
| Body Mass Index (BMI) | 24.3 kg/m^2 STANDARD_DEVIATION 4.42 | — |
| Charlson Comorbidity Scale 0 | 119 Participants | — |
| Charlson Comorbidity Scale 1 | 59 Participants | — |
| Charlson Comorbidity Scale 2 | 36 Participants | — |
| Charlson Comorbidity Scale 3 | 18 Participants | — |
| Charlson Comorbidity Scale 4 | 11 Participants | — |
| Charlson Comorbidity Scale 5 | 7 Participants | — |
| Charlson Comorbidity Scale 6 | 2 Participants | — |
| Charlson Comorbidity Scale 7 | 1 Participants | — |
| Charlson Comorbidity Scale 8 | 1 Participants | — |
| Charlson Comorbidity Scale 9 | 1 Participants | — |
| Height | 161.81 cm STANDARD_DEVIATION 7.22 | — |
| Neck circumference | 35.74 cm STANDARD_DEVIATION 4.51 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Taiwan | 255 participants | — |
| Sex: Female, Male Female | 183 Participants | — |
| Sex: Female, Male Male | 72 Participants | — |
| Weight | 63.82 kg STANDARD_DEVIATION 13.44 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 255 |
| other Total, other adverse events | 0 / 255 |
| serious Total, serious adverse events | 0 / 255 |
Outcome results
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)
Time frame: up to 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Airmod | Test of the Difference Between airRR and mancRR | mancRR - airRR | 0.422 breaths per minute |
| Airmod | Test of the Difference Between airRR and mancRR | airRR | 14.362 breaths per minute |
| Airmod | Test of the Difference Between airRR and mancRR | mancRR | 14.784 breaths per minute |
Comparison: Hypothesis: airRR-mancRR ≦ -3, In the target of p\<0.05 indicates significance.p-value: <0.001Paired t Test
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)
Time frame: up to 4 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Airmod | 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 | airRR | 14.25 breaths per minute | Standard Deviation 4.15 |
| Airmod | 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 | acoRR | 13.14 breaths per minute | Standard Deviation 5.31 |
| Airmod | 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 | airRR-acoRR | 1.11 breaths per minute | Standard Deviation 3.71 |
Comparison: In this study, a non-inferiority test was conducted during periods of reduced sensitivity in capnography to compare respiratory rate measurements using the Airmod device (airRR) versus manually scored auscultation sounds (referred to as acoRR, implying manARR in the statistical analysis plan). The research physician identified periods of reduced sensitivity in capnography.p-value: <0.001Paired t Test
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).
Time frame: up to 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Airmod | 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 | mancRR - airRR | 0.422 breaths per minute |
| Airmod | 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 | airRR | 14.362 breaths per minute |
| Airmod | 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 | mancRR | 14.784 breaths per minute |
Comparison: Hypothesis: airRR-mancRR ≦ -2, In the target of p\<0.05 indicates significance.p-value: <0.05Paired t Test
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).
Time frame: up to 4 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Airmod | Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period | Airmod | 12.61 sec | Standard Deviation 14.03 |
| Airmod | Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period | Capnography | 28.93 sec | Standard Deviation 20.62 |
| Airmod | Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period | Airmod-Capnography | -16.32 sec | Standard Deviation 21.83 |
Comparison: The hypothesis tested whether the response times obtained with the Airmod device were equal to those recorded with Capnography.p-value: <0.001Paired t Test
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).
Time frame: up to 4 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Airmod | Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) | manCRR - airRR | 0.42155 breaths per minute |
| Airmod | Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) | manCRR - capRR | -0.0009 breaths per minute |
| Airmod | Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) | manCRR - acoRR | 0.31701 breaths per minute |
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.
Time frame: In the study , All participants spend less than 30 min writing thesis questionnaire.
Population: airmod operator
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Airmod | Safety and Usability of Airmod. | Were you able to complete this study? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to turn on Airmod APP? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to connect Airmod APP to AS-101? (Yes:1, No:0) | 7 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to record the breath sound ? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to key in patient's info? (Yes:1, No:0) | 7 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to adjust the sound playback mode? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to stop the breath sound recording ? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to adjust settings? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Were you able to review patient's breath sound recording? (Yes:1, No:0) | 8 participants |
| Airmod | Safety and Usability of Airmod. | Overall, were you able to use Airmod APP? (Yes:1, No:0) | 8 participants |