on-invasive evaluation of the pediatric intracranial pressure
- Conditions
- PediatricsC10.228.140.602Intracranial Pressure
- Registration Number
- RBR-5j74ddg
- Lead Sponsor
- Hospital Pequeno Príncipe
- Brief Summary
Introduction: Intracranial hypertension (HI) is a secondary clinical condition resulting from the loss of controlled compensatory controls, leading to increased intracranial pressure (ICP) and changes in cerebral blood flow, which may result in hypoxia, brain damage and hernia. Brain4care (b4c) is a device that explores variations in intracranial compliance and allows the measurement of ICP in a non-invasive and serial way, in addition, it can predict the trend of evolution of the clinical syndrome of HI. Objective: To evaluate the concordance of monitoring with the Brain4care device in acute changes in intracranial compliance with CSF puncture with manometry. Hypothesis that Brain4care can be used as a tool to aid in the detection of intracranial compliance variation. Method: Observational and cross-sectional study, carried out in a reference pediatric hospital in Brazil, in patients with signs and symptoms of IH and neurologically healthy patients. After neurological medical evaluation, the following tests were performed – non-invasive monitoring of ICP with B4C, ophthalmoscopy, tomography (CT), magnetic resonance imaging (MRI) and lumbar puncture and brain4care monitoring. Result: Performed to date the epidemiological profile of patients with signs and symptoms of intracranial hypertension, 58 patients with signs and symptoms of intracranial hypertension were evaluated, 32 females (55.2%), 26 males (44, 8%) and a median age was 10 (3-17). Most patients had symptoms such as drowsiness (81%), nausea (77.6%), headache (74.1%), vomiting (63.8%) and dizziness (53.4%). The ophthalmological examination in 77.6% (n=58) of the patients showed no signs of papilledema. At CT and MRI, no alterations were found in 84.5% (n=58) and 69.2% (n=26), respectively. Lumbar puncture was abnormal in 57.1% (n=21). Based on published studies of b4c values in the adult population, monitoring with the device (N=58) showed a possible change in sitting and lying position of 46.3% and 38.9% respectively in pediatric patients. Conclusion So far, it has been possible to describe the profile of pediatric patients monitored by a non-invasive device with signs and symptoms of IH, which has not yet been described in the literature. Furthermore, the b4c device provides a possible complement of clinical information in the brain compliance monitoring process.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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)
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to find correlation between the initial neurological signs and symptoms with the braincare device signal and the clinical outcome
- Secondary Outcome Measures
Name Time Method Evaluate the agreement between the diagnostic imaging exams for signs and symptoms intracranial hypertension with the braincare device signal