NCT06038513终止不适用
A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- CoolTech LLC
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Time to achieve normothermia (≤37.5°C)
研究概览
简要总结
The objective of this study is to evaluate the efficacy 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
- •Ages 18-85 years, inclusive.
- •Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
- •Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
- •Glasgow Coma Scale score of 3-11, inclusive.
- •Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.
排除标准
- •Intubation is contraindicated.
- •Weight of ≤ 100lb or ≥ 250lb.
- •Active/ongoing epistaxis.
- •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.
- •Nasal septal deviations (per standard of care CT scan; any degree).
- •Chronic rhinosinusitis.
- •Traumatic brain injury.
- •Prior skull-base surgery.
- •Penetrating cranial trauma.
- •Recent nasal trauma or anterior base skull fracture.
- •Any condition for which transnasal air flow would be contraindicated.
- •Refractory hypoxemia (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 0.60).
- •Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
研究组 & 干预措施
Transnasal Thermal Regulating Device
Experimental
Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours
干预措施: Transnasal Thermal Regulating Device (Device)
结局指标
主要结局
Time to achieve normothermia (≤37.5°C)
时间窗: 24 hours
To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
次要结局
- Incidence of shivering during cooling period(24 hours)
- Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period(24 hours)
- Number of shivering interventions per patient(24 hours)
- Incidence of adverse events.(24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Transnasal Induction of Normothermia in Febrile Stroke PatientsStroke, IschemicStroke HemorrhagicFeverSeizuresMetabolic EncephalopathyNCT03360656CoolTech LLC30
已完成
不适用
BrainCool-Migraine Intranasal Cooling TrialMigraineNCT03167060Cumbria Partnership NHS Foundation Trust90
终止
不适用
Transnasal Cooling for MigraineEpisodic MigraineMigraineMigraine With AuraMigraine Without AuraNCT04936061CoolTech LLC24
终止
不适用
Intranasal Cooling for Symptomatic Relief of MigraineMigraine HeadacheNCT02375789Cumbria Partnership NHS Foundation Trust27
已完成
不适用
The Effect of Thermal Evaluation in Prevention of Diabetic Foot UlcerDiabetic FootNCT04480801Fatma Özkal70