NCT03360656已完成不适用
Transnasal Induction of Normothermia in Febrile Stroke Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CoolTech LLC
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Cooling Performance
研究概览
简要总结
The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the Neurosciences Critical Care Unit (NCCU).
- •Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
- •Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
- •Planned stay in NCCU > 24 hours.
- •Must have informed consent from the patient or the legally authorized representative (LAR)
排除标准
- •Age < 18 years old or > 95 years.
- •Intubation is contraindicated.
- •With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
- •Hemodynamic instability, including elevated SPB for >5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
- •History of cryoglobulinemia.
- •History of sickle cell disease.
- •History of serum cold agglutinin disease.
- •Active/ongoing of nose bleeds.
- •Known or suspected pregnancy.
- •Participation in another ongoing investigational study.
- •Prisoners and/or patients for whom no LAR is available.
- •Patient is in airborne/droplet disease isolation protocol.
- •Patient is or suspected to be immunocompromised;
- •Low platelet count defined as < 100k (thrombocytopenia).
- •Nasal septal deviations (per CT scan; any degree).
- •Chronic rhinosinusitis.
- •Prior skull-based surgery
- •Penetrating cranial trauma.
- •Recent nasal trauma or anterior base skull fracture.
- •Presence of cardiac arrhythmias including: sustained tachycardia defined as heart rate above 120 beats per minute, or sustained bradycardia defined as heart rate below 60 beats per minute.
- •Refractory hypoxemia defined as partial pressure of oxygen in arterial blood (paO2) below 60 torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical ventilation, and provision of supplemental oxygen of up to 0.
- •Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.
- •History of cardiac arrhythmia as listed above.
- •BMI of ≤ 15 kg/m2 or ≥ 40kg/m2
结局指标
主要结局
Cooling Performance
时间窗: 4 hours
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
次要结局
未报告次要终点
研究者
研究点 (6)
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