Evaluating the Non-Inferiority of Airmod to Capnostream™35 on Respiratory Rate Monitoring and User Experience Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 6
- 主要终点
- Test of the Difference Between airRR and mancRR
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Test of the Difference Between airRR and mancRR
时间窗: 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)
次要结局
- 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.)