Department of Neurology, University of Louisville School of Medicine, Louisville, KY 40202, USA.
Stroke. 2011 Aug;42(8):2164-9. doi: 10.1161/STROKEAHA.110.613000. Epub 2011 Jun 16.
Hypothermia is neuroprotectant but currently available cooling methods are laborious, invasive, and require whole-body cooling. There is a need for less invasive cooling of the brain. This study was conducted to assess the safety and efficacy of temperature reduction of the RhinoChill transnasal cooling device.
We conducted a prospective single-arm safety and feasibility study of intubated patients for whom temperature reduction was indicated. After rhinoscopy, the device was activated for 1 hour. Brain, tympanic, and core temperatures along with vital signs and laboratory studies were recorded. All general and device-related adverse events were collected for the entire hypothermia treatment.
A total of 15 patients (mean age, 50.3 ± 17.1 years) were enrolled. Brain injury was caused by intracerebral hemorrhage, trauma, and ischemic stroke in equal numbers. Hypothermia was induced for fever control in 9 patients and for neuroprotection/intracranial pressure control in 6. Core temperature, brain temperature, and tympanic temperature were reduced an average of 1.1 ± 0.6°C (range, 0.3 to 2.1°C), 1.4 ± 0.4°C (range, 0.8 to 5.1°C), and 2.2 ± 2°C (range, 0.5 to 6.5°C), respectively. Only 2 patients did not achieve the goal of ≥1°C decrease in temperature. Brain temperature, tympanic temperature, and core temperature reductions were similar between the afebrile and febrile patients. There were no unanticipated adverse events and only 1 anticipated adverse event: hypertension in 1 subject that led to discontinuation of cooling after 30 minutes. There were no nasal complications.
Intranasal cooling with the RhinoChill device appears safe and effectively lowers brain and core temperatures. Further study is warranted to assess the efficacy of hypothermia through intranasal cooling for brain-injured patients.
低温具有神经保护作用，但目前可用的冷却方法既费力又具侵入性，且需要全身冷却。因此，需要一种侵入性更小的脑部冷却方法。本研究旨在评估 RhinoChill 经鼻冷却装置降温的安全性和有效性。
我们对需要降温的插管患者进行了一项前瞻性、单臂、安全性和可行性研究。鼻镜检查后，将设备激活 1 小时。记录脑温、鼓膜温度和核心温度以及生命体征和实验室研究。收集整个低温治疗过程中的所有一般和与设备相关的不良事件。
共纳入 15 例患者（平均年龄 50.3±17.1 岁）。脑损伤由脑出血、创伤和缺血性卒中引起的比例相等。9 例患者因发热控制，6 例患者因神经保护/颅内压控制而诱导低温。核心温度、脑温度和鼓膜温度平均降低 1.1±0.6°C（范围 0.3 至 2.1°C）、1.4±0.4°C（范围 0.8 至 5.1°C）和 2.2±2°C（范围 0.5 至 6.5°C）。仅 2 例患者未达到体温降低≥1°C的目标。发热和不发热患者的脑温、鼓膜温度和核心温度降低无显著差异。无意外不良事件，仅 1 例预期不良事件：1 例患者发生高血压，冷却 30 分钟后停止。无鼻腔并发症。
使用 RhinoChill 装置经鼻冷却似乎安全有效，可以降低脑温和核心温度。需要进一步研究评估经鼻冷却对脑损伤患者的降温效果。
