RBR-5dm7g2
Not yet recruiting
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 sitesApril 25, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Craniocerebral Trauma
- Sponsor
- niversidade Federal de São Paulo
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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