Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Body Temperature
研究概览
简要总结
This is a human non-significant risk (NSR) clinical study designed to objectively and participatively verify that the Carecube Negative Pressure Isolation Chamber is a safe and non-hostile environment for the patients that will be contained within the chamber during normal operations.
详细描述
Device Information:
The Carecube Negative Pressure Isolation Chamber is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment.
Study Description:
Participants will be tasked to stay within the Carecube Negative Pressure Isolation Chamber for a minimum of three consecutive time points (1 hour apart) illustrating a plateau level for all parameters, up to a maximum of 7 hours (readings will be taken at baseline and hourly thereafter).
The Carecube Negative Pressure Isolation Chamber will be set up indoors, in an emergency department and hospital floor environment. We will collect data and demonstrate that the Carecube Isolation chamber is a safe and non-hostile environment for the patients that will be contained within, during normal operations.
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
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, female, non-binary between the ages of 19-65 No existing medical condition that would impact the Subject from staying within the containment system for the specified time-period.
- •Patient is not pre-dispositioned for claustrophobia
排除标准
- •Subjects that have a pre-existing condition of claustrophobia Subjects that have a history of hypertension Subjects with a clinical diagnosis of generalized anxiety disorder (GAD) Subjects with a clinical diagnosis of major depressive disorder (MDD) Morbidly obese patients (BMI above 40) Subjects who are Women of Child Bearing Potential (WOCBP) who either are pregnant or suspect they are pregnant
结局指标
主要结局
Body Temperature
时间窗: 4 hours
Subject's body temperature maintains a normal healthy value based on their entry body temperature and outside the Carecube
Pulse
时间窗: 4 hours
Subject's pulse stays within a normal healthy level based with respect to their initial baseline
Blood Pressure
时间窗: 4 hours
Subject's blood pressure stays at a normal healthy level with respect to their initial baseline
Environmental Condition
时间窗: 4 hours
Environment does not have an elevation of temperature, Carbon Dioxide and humidity outside a normal range as compared to the external environment of the chamber.
Communication
时间窗: 4 hours
Subject and provider are able to clearly and effectively communicate while the Subject is positioned within the Carecube Negative Pressure Isolation Chamber.
Oxygen levels
时间窗: 4 hours
Subject's Oxygen levels stays within a normal healthy level based with respect to their initial baseline
Movement
时间窗: 4 hours
Subject is able to move within the Carecube, to include activities such as sitting up, laying down, rotating, foot flexion or other body positioning within the hospital bed located within the Carecube.
次要结局
- Anxiety(4 hours)
- Comfort(4 hours)