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临床试验/RBR-5dm7g2
RBR-5dm7g2尚未招募未知

Efficacy and Safety of Hypothermia Cerebral Exclusive deployment through the use of catheter Nasopharyngeal in Human Beings for the treatment of seriuos (ou (severe) brain trauma Phase I Study

niversidade Federal de São Paulo0 个研究点开始时间: 2016年4月25日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Intervention

入排标准

年龄范围
18Y 至 70Y(—)

入选标准

  • Patients both male and female aged 18 to 70 years; Confirmed diagnosis of TBI; Glasgow Coma Scale 8; Use of definitive airway devices (tracheal tube, tracheostomy or cricotireoideostomia); Ssaturation of oxygen (O2) blood above 92%; Monitoring Indication of PIC by the neurosurgery team responsible for the case; patients, or their legal representatives who signed the informed consent.

排除标准

  • Patients with early brain temperature <35.5 ° C; Pregnancy known or obvious; Obstructive lesions of the upper airways; Confirmed diagnosis of skull base fracture or cerebrospinal fluid leaks evident nasally; Diagnosis cervical spine fracture confirmed with contraindications to cervical mobilization, even with the use of cervical collar; Blood Pressure 6-average <65 mmHg in the last two hours; Use of antibiotics in the last two hours or signs of current infection or sepsis; Known use of anticoagulants in therapeutic dose; Bleeding not controlled; Signs of brain death or borderline flow by transcranial Doppler (TCD); Glasgow Coma Scale 3 associated with pupils without photoreaction; Current participation in another clinical study in progress.

研究者

发起方
niversidade Federal de São Paulo

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