Intracranial Pressure
Conditions
Interventions
This is a non-randomized, observational, prospective clinical trial to evaluate the Brain4care device in patients with and without signs and symptoms of intracranial hypertension. There will be no int
V03.175.500
Sponsors
Hospital Pequeno Príncipe
Braincare Desenvolvimento e Inovação Tecnológica S.A.
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: AActive group: Patients aged 2 to 17 years 11 months and 29 days; Patients of both sexes; Patients who show signs and symptoms of probable intracranial hypertension such as; headache; visual changes; nausea;vomiting; irritability; cognitive changes; changes in level of consciousness; apilledema; Patients in which a parent or legal guardian consents and signs the Informed Consent Form (ICF); Patient who consents and signs the Informed Consent Form (TALE). Control Group: Patients aged 2 to 17 years 11 months and 29 days; Patients of both sexes;Patients who present neurological examination, performed by a qualified doctor; within the normal range; Healthy patients, selected according to a previous questionnaire with no signs and symptoms related to ICH (headache, visual changes; nausea; vomiting; irritability; cognitive changes; changes in level of consciousness; papilledema); Patients in which a parent or legal guardian consents and signs the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Active group: Recent surgery with manipulation of the scalp; this reduces the possibility of post-operative control. Sedation that interferes with the measurement of intracranial compliance; Patient outside the chosen pediatric age group; Cranial deformities that prevent the placement of the sensor; Extensive scalp lesion; Patients who do not accept monitoring through the Brain4care device; Patient with complementary Brain Death clinic / exams; Patients in whom the legal guardian or a parent does not consent to participation; Control Group: Patients outside the age range defined for the study; Patients who present signs and symptoms of ICH; Patients with signs and symptoms of neurological degradation; Rheumatological patients; Neurological patients; Cardiac patients; Nephrological patients; Respiratory patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find correlation between the initial neurological signs and symptoms with the braincare device signal and the clinical outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the agreement between the diagnostic imaging exams for signs and symptoms intracranial hypertension with the braincare device signal | — |
Countries
Brazil
Contacts
Public ContactMarinei Ricieri
Hospital Pequeno Príncipe
Outcome results
None listed