Craniocerebral Trauma
Conditions
Interventions
10 participants
Nasopharyngeal cooling treatment for a period of 24 hours
Device
Dietary supplement
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to 70 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the following clinical parameters before the intervention, under the influence of selective brain hypothermia and after the intervention: nasofibroscopy to macroscopic classification of the degree of damage to the nasal mucous and nasopharyngeal, when present; analysis of speed variations of cerebral blood flow (transcranial Doppler), analysis of changes in hemodynamic data, defined as systolic volume (SV) and cardiac output (CO) were obtained by minimally invasive monitoring with Flotrac® / Vigileo® system; analysis of variations in heart rate (HR), analysis of variations in mean arterial pressure (PAM); analysis of changes in clotting factors (RNI and TTPa), analysis of changes in electrolytes - sodium (Na +) and potassium (K +); analysis of changes in leukocyte and platelet count; incidence of adverse events and adverse events related to the intervention.;Percentage of participants normothermic, defined as systemic temperature 36 and 37 ° C, measured by rectal thermometer (preferred), esophageal or bladder for at least 90% of the total period of 24 h intervention (corresponds to 22 h 30 min ); Percentage of responders in 120 min after the start of cooling, as measured by PIC catheter with intracerebral ventricular or temperature sensor; Difference between brain temperature basal (mean basal measurement) and brain temperature with in 120 min after the start of cooling (mean of measurements in the period) in the group of responders and non-responders; Difference between brain temperatures obtained by BTT sensor and obtained by PIC catheter during 24 hours of the intervention; | — |
Countries
Brazil
Contacts
Public ContactBernardo Paiva
Universidade Federal de São Paulo
Outcome results
None listed