Respiratory Rate Validation Study - Gabi SmartCare Gabi Band
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min
研究概览
简要总结
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda) by manually scoring the collected waveform for data analysis.
详细描述
Each participant is expected to take 1-2 hours, including paperwork, sensor application, and a maximum of 60 minutes of data collection. Each participant will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and the Gabi SmartCare Gabi Band. The end tidal carbon dioxide (EtCO2) monitor will determine performance of respiratory rate metrics (GE Healthcare S5 Compact Monitor with M-COVX (K001814) or E-CaiO (K051092) modules). Each participant will be instrumented with neonatal or pediatric nasal cannula that allows for measurement of the EtCO2. SpO2 sensors may be placed on the feet and/or toes for safety monitoring purposes.
Data will be simultaneously and continuously recorded from the Reference EtCO2 monitor and the Device Under Test (DUT). Periods of quiet will be encouraged. Data will be marked for stable quiet periods that are useable for analysis. There is no additional follow-up required for the investigation.
One minute epochs will be generated from the stable data periods for analysis. For verification, the Reference EtCO2 waveform will be scored by counting the respiratory peaks per minute.
The reviewers counting the raw EtCO2 waveform will be blinded to the results from the test device. The DUT data will be averaged over the corresponding one minute period. The Accuracy root- mean-square (Arms) will be the basis for evaluation and acceptance.
To 'Pass' this test the Gabi SmartCare Gabi Band (Device Under Test) must demonstrate an Accuracy root-mean- square (Arms) of ≤3.0 breaths per minute when compared to the Reference EtCO2 monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability of the parent or guardian to understand and provide written informed consent
- •Participant is 0 to 12 years of age
- •Subjects that are between 7 and 12 years of age must provide Assent to participate in the study
排除标准
- •Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Participant Demographics and Screening Record Form
- •Participant has injuries, deformities or abnormalities that may prevent proper application of the device under test
- •Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
研究组 & 干预措施
Pediatrics population
干预措施: Respiratory rate measure based on PPG (Device)
结局指标
主要结局
Accuracy of Device Under Test for the Measurement of Respiratory Rate, Measured in Breath/Min
时间窗: Every 60 seconds, over a total duration of maximum 60 minutes
Arms or rms error, given in breath per minute, is the calculation of root mean square between Respiratory rate of the subject device and the manually scored reference Respiratory Rate EtCO2 waveform, for all stable respiratory periods. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurement to a "rms error". It indicates how far (accurate) the provided value is from the reference used. A passing result required an Arms of ≤3 breaths/min.
次要结局
未报告次要终点