Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- lower core body temperature
研究概览
简要总结
The objective of this study is to evaluate the performance and safety of the VCool Intranasal Cooling System in healthy adult volunteers. The study is designed to gather preliminary data regarding air flow rates and time required to reduce core body temperature to 35.5℃ and maintain the temperature between 35℃ and 36℃ for one hour after cooling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ages 18 to
- •An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- •Baseline core body temperature between 36.8℃ and 37.5℃.
- •Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
- •In the opinion of the Investigator, are able to participate in the study.
排除标准
- •History of cardiovascular, respiratory, or metabolic disorder
- •Any contraindication to undergoing Magnetic Resonance Imaging (MRI)
- •Severe peripheral vascular disease
- •History of Raynaud's disease
- •Currently experiencing a respiratory infection
- •Chronic rhinosinusitis
- •History of sickle cell disease
- •History of cold agglutinin disease
- •History of cryoglobulinemia
- •Known deviated septum or nasal deformity
- •History of nosebleeds or a nosebleed within past 24 hours
- •Use of antipyretics or other medications affecting body temperature within the past 24 hours.
研究组 & 干预措施
Healthy adult volunteers
The study is designed to gather preliminary data regarding air flow rates and time required to reduce core body temperature to 35.5℃ and maintain the temperature between 35℃ and 36℃ for one hour after cooling.
干预措施: Targeted Temperature Management Intranasal Cooling System (Device)
结局指标
主要结局
lower core body temperature
时间窗: 1 hour
To confirm the VCool System can lower core body temperature to 35.5℃.
maintain a core body temperature
时间窗: 1 hour
To confirm the VCool System can maintain a core body temperature between 35℃ and 36℃ for one hour after cooling.
differential between core body and brain temperature
时间窗: 2 hours
To evaluate the differential between core body and brain temperature while using VCool.
次要结局
- Bedside Shivering Assessment Scale (BSAS).(2 hours)
研究者
Bryan Wand
Director of Engineering
NeuroIntact Inc.