Respiratory Rate Accuracy - Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Respiratory Rate Accuracy
研究概览
简要总结
The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.
详细描述
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Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
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Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
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Collect Demographic and Anthropometric Data from the subject.
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Place Pulse Oximetry Sensors
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Place nasal cannula for capnography recordings
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A summary of Respiratory rate protocol.
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Stage 1: Subject will rest quietly and breathe at a normal comfortable rate for 40 minutes. The start and stop times will be marked on the data collection system.
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Stage 2: Immediately after Stage 1 is complete, the subject will start the 25 minute paced breathing protocol which will ramp from 5-45 BPM. A computer program will be used to guide the subject through the stage 2 paced breathing. The start and stop times will be marked on the data collection system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female
- •The subject is of any racial or ethnic group
- •The subject is > 30 kg (>66 pounds) in weight (based on measurement)
- •The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
- •The subject is between 18 years and 50 years of age (self-reported)
- •The subject has given written informed consent to participate in the study
- •The subject is both willing and able to comply with study procedures.
排除标准
- •The subject has a BMI greater than 30 (based on weight and height)
- •The subject has a history of atrial fibrillation (self-reported)
- •The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds (self-reported)
- •The subject has an implanted pacemaker (self-reported)
- •The subject has had any relevant injury at the sensor location site (self-reported)
- •The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
- •The subject has a known respiratory condition (self-reported)
- •The subject has a known heart or cardiovascular condition (self-reported)
- •The subject is currently pregnant (self-reported)
- •The subject is actively trying to get pregnant (self-reported)
- •The subject is unwilling or unable to provide written informed consent to participate in the study
- •The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
结局指标
主要结局
Respiratory Rate Accuracy
时间窗: 3 months
Values from the test device will be compared to the values from co-oximetry devices
次要结局
未报告次要终点