Study to evaluate the efficacy and safety of the implant of Cerebral Hypothermia Exclusive by Nasopharyngeal (posterior region of the nose) Catheter use to Treatment of severe Head trauma

Not Applicable

• Conditions: Craniocerebral Trauma; Intracranial injury, unspecified; Coma; Hypothermia, Induced; C10.900.300; S06.9; C10.597.606.358.800.200; E02.258.750

• Registration Number: RBR-5dm7g2
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of respondents considering responder as every participant who meets the following two criteria: reducing brain temperature by at least 2 ° C during the intervention period (24 h) with respect to the basal temperature, as measured by catheter PIC with intraparenchymal or ventricular temperature sensor; and maintaining the brain temperature below the systemic temperature at least 2 ° C for at least 90% of the total period of 24 h intervention (which corresponds to 22 h 30 min).<br>