Final Test Report for Vital USA Respiratory Rate Validation In Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.
研究概览
简要总结
Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.
详细描述
Purpose of Clinical Investigation Respiratory Rate is an important physiological measurement in the healthcare setting. End Tidal Carbon Dioxide (EtCO2) is considered to be the highest level of safety and accuracy in Respiratory Rate monitoring by the American Society of Anesthesiology and the American Association of Respiratory Care.
The purpose of this study was to conduct a Respiratory Rate accuracy validation comparing the Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).
Respiratory Rate is an important physiological measurement in the healthcare setting. End Tidal Carbon Dioxide (EtCO2) is considered to be the highest level of safety and accuracy in Respiratory Rate monitoring by the American Society of Anesthesiology and the American Association of Respiratory Care.
The purpose of this study was to conduct a Respiratory Rate accuracy validation comparing the Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).
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
- 18 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have the ability to understand and provide written informed consent
- •Subject is adult over 18 years of age
- •Subject must be willing and able to comply with study procedures and duration
- •Subject is a non-smoker
- •Male or female of any race
排除标准
- •Subject is considered as being morbidly obese (defined as BMI >39.5)
- •Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- •Subjects with known respiratory conditions such as:
- •uncontrolled / severe asthma,
- •pneumonia / bronchitis,
- •shortness of breath / respiratory distress,
- •respiratory or lung surgery,
- •emphysema, COPD, lung disease
- •Subjects with self-reported heart or cardiovascular conditions such as:
- •have had cardiovascular surgery
- •Chest pain (angina)
- •heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- •previous heart attack
- •blocked artery
- •unexplained shortness of breath
- •congestive heart failure (CHF)
- •history of stroke
- •transient ischemic attack
- •carotid artery disease
- •myocardial ischemia
- •myocardial infarction
- •cardiomyopathy
- •Self-reported health conditions as identified in the Health Assessment Form
- •diabetes,
- •uncontrolled thyroid disease,
- •kidney disease / chronic renal impairment,
- •history of seizures (except childhood febrile seizures),
- •epilepsy,
- •history of unexplained syncope,
- •recent history of frequent migraine headaches,
- •recent head injury within the last 2 months,
- •Cancer / chemotherapy
- •Other known health condition, should be considered upon disclosure in health assessment form
结局指标
主要结局
Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.
时间窗: 20 Seconds
The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).The endpoint of interest was accuracy as measured by the Accuracy root-mean-square (ARMS) difference between the Device Under Test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods.
次要结局
未报告次要终点