Spire Medical Health Tag Respiratory Rate Validation in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spire, Inc.
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- measurement of respiratory rate to the Reference
研究概览
简要总结
The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).
After IRB approval, a minimum of 20 healthy volunteer test subjects, 18 or older will be entered into this study designed to validate the accuracy of the respiratory rate feature of the Spire Medical Health Tag (Device Under Test).
The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMIs. Each subject will be connected to a FDA cleared EtCO2 monitor (GE Datex-Ohmeda) and will be instrumented with a mouthpiece or open system mask that allows for measurement of EtCO2 derived respiratory rate. A range of stable respiratory rates will be elicited from each volunteer test subject with the use of a paced breathing application on a mobile phone. Subjects will also be connected to a 3-lead ECG (GE Datex-Ohmeda) for the purpose of monitoring heart rate and comparing to the pulse rate measurements recorded by the Spire Medical Health Tag.
The respiratory rate and pulse rate will be measured simultaneously for the Reference and the Device Under Test.
详细描述
The purpose of this study is to collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2. A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3-lead ECG will be used for the Respiratory and Pulse Rate References. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
This study will focus on the respiratory rate, RR parameter. The Spire Medical Health Tag is investigational and has not been cleared by the FDA. The intended purpose of the device under test is spot-checking, non-invasive monitoring / logging of respiratory rate on humans. For this evaluation, the device will be run in a continuous data collection mode.
The study population will include 20 healthy competent adults, ages 18 years and older. The subject selection will be a mix of males and females with small to large physiques. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form and passing the health screening. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.
It is expected that the data collection will take approximately 4-7 days to complete. There is no additional followup required for the investigation.
The data from the Device Under Test will be collected on an application installed on the iOS or Android mobile device separate from the reference equipment.
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
- 18 Years 至 —（Adult, Older 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
研究组 & 干预措施
Spire Medical Health Tag
Spire Medical Health Tag is worn by all subjects The study is open label
干预措施: Spire Medical Health Tag (Device)
结局指标
主要结局
measurement of respiratory rate to the Reference
时间窗: 60 seconds
The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the Device Under Test (DUT) and the Reference EtCO2 (Ref) for all stable respiratory periods
次要结局
未报告次要终点