[Small tidal volume hyperventilation relieves intraocular and intracranial pressure elevation in prone spinal surgery: a randomized controlled trial].

OBJECTIVE: To investigate the effects of different ventilation strategies on intraocular pressure (IOP) and intracranial pressure in patients undergoing spinal surgery in the prone position under general anesthesia. METHODS: Seventy-two patients undergoing prone spinal surgery under general anesthesia between November, 2022 and June, 2023 were equally randomized into two groups to receive routine ventilation (with Vt of 8mL/kg, Fr of 12-15/min, and etCO2 maintained at 35-40 mmHg) or small tidal volume hyperventilation (Vt of 6 mL/kg, Fr of18-20/min, and etCO2 maintained at 30-35 mmHg) during the surgery. IOP of both eyes (measured with a handheld tonometer), optic nerve sheath diameter (ONSD; measured at 3 mm behind the eyeball with bedside real-time ultrasound), circulatory and respiratory parameters of the patients were recorded before anesthesia (T0), immediately after anesthesia induction (T1), immediately after prone positioning (T2), at 2 h during operation (T3), immediately after supine positioning after surgery (T4) and 30 min after the operation (T5). RESULTS: Compared with those at T1, IOP and ONSD in both groups increased significantly at T3 and T4(P < 0.05). IOP was significantly lower in hyperventilation group than in routine ventilation group at T3 and T4(P < 0.05), and ONSD was significantly lower in hyperventilation group at T4(P < 0.05). IOP was positively correlated with the length of operative time (r=0.779, P < 0.001) and inversely with intraoperative etCO2 at T3(r=-0.248, P < 0.001) and T4(r=-0.251, P < 0.001).ONSD was correlated only with operation time (r=0.561, P < 0.05) and not with IOP (r=0.178, P>0.05 at T3; r=0.165, P>0.05 at T4). CONCLUSION: Small tidal volume hyperventilation can relieve the increase of IOP and ONSD during prone spinal surgery under general anesthesia.

Effect of different positive end expiratory pressure levels on optic nerve sheath diameter in patients with or without midline shift who are undergoing supratentorial craniotomy.

PURPOSE: In general, high levels of PEEP application is avoided in patients undergoing craniotomy to prevent a rise in ICP. But that approach would increase the risk of secondary brain injury especially in hypoxemic patients. Because the optic nerve sheath is distensible, a rise in ICP is associated with an increase in the optic nerve sheath diameter (ONSD). The cutoff value for elevated ICP assessed by ONSD is between 5.6 and 6.3 mm. We aimed to evaluate the effect of different PEEP levels on ONSD and compare the effect of different PEEP levels in patients with and without intracranial midline shift. METHODS: This prospective observational study was performed in aged 18-70 years, ASA I-III, 80 patients who were undergoing supratentorial craniotomy. After the induction of general anesthesia, the ONSD's were measured by the linear transducer from 3 mm below the globe at PEEP values of 0-5-10 cmH2O. The ONSD were compered between patients with (n = 7) and without midline shift (n = 73) at different PEEP values. RESULTS: The increases in ONSD due to increase in PEEP level were determined (p < 0.001). No difference was found in the comparison of ONSD between patients with and without midline shift in different PEEP values (p = 0.329, 0.535, 0.410 respectively). But application of 10 cmH2O PEEP in patients with a midline shift increased the mean ONSD value to 5.73 mm. This value is roughly 0.1 mm higher than the lower limit of the ONSD cutoff value. CONCLUSIONS: The ONSD in adults undergoing supratentorial tumor craniotomy, PEEP values up to 5 cmH2O, appears not to be associated with an ICP increase; however, the ONSD exceeded the cutoff for increased ICP when a PEEP of 10 cmH2O was applied in patients with midline shift.

Venous sinus stenting for idiopathic intracranial hypertension: An updated Meta-analysis.

BACKGROUND: Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure and primarily affects obese women of reproductive age. Venous sinus stenting (VSS) is a surgical procedure used to treat IIH, but its safety and efficacy are still controversial. METHODS: A systematic review and meta-analysis were conducted following PRISMA guidelines. Multiple databases were searched for studies evaluating the safety and efficacy of VSS in IIH patients and meta-analysis was performed to pool the data. RESULTS: A total of 36 studies involving 1066 patients who underwent VSS were included. After VSS, a significant reduction in trans-stenotic gradient pressure was observed. Patients also showed significantly lower cerebrospinal fluid (CSF) opening pressure. Clinical outcomes demonstrated improvement in tinnitus (95%), papilledema (89%), visual disturbances (88%), and headache (79%). However, 13.7% of patients experienced treatment failure or complications. The treatment failure rate was 8.35%, characterized by worsening symptoms and recurrence of IIH. The complications rate was 5.35%, including subdural hemorrhage, urinary tract infection, stent thrombus formation, and others. CONCLUSION: VSS appears to be a safe and effective treatment option for IIH patients who are unresponsive to medical therapy or have significant visual symptoms. However, long-term outcomes and safety of the procedure require further investigation.

Intracranial Hypertension Associated With Poly-Cranio-Radicular-Neuropathies: A Case Report and Review of the Literature.

INTRODUCTION: We present the case of a gentleman who developed rapidly progressive vision loss, ophthalmo-paresis, and flaccid quadriparesis in the context of severe intracranial hypertension. We reviewed the available cases in the literature to increase awareness of this rare clinical entity.Case Report:A 36-year-old man developed rapidly progressive vision loss, ophthalmo-paresis, and flaccid quadriparesis. He had an extensive workup, only notable for severe intracranial hypertension, >55 cm of H 2 O. No inflammatory features were present, and the patient responded to CSF diversion. Few similar cases are available in the literature, but all show markedly elevated intracranial pressure associated with extensive neuroaxis dysfunction. Similarly, these patients improved with CSF diversion but did not appear to respond to immune-based therapies. CONCLUSIONS: We term this extensive neuroaxis dysfunction intracranial hypertension associated with poly-cranio-radicular-neuropathy (IHP) and distinguish it from similar immune-mediated clinical presentations. Clinicians should be aware of the different etiologies of this potentially devastating clinical presentation to inform appropriate and timely treatment.

A comparison of the surgical outcomes of ventriculoperitoneal versus lumbar peritoneal shunts in the management of intracranial hypertension secondary to cryptococcal meningitis in HIV infected adult patients.

OBJECTIVE: Cryptococcal meningitis (CM), an AIDS-defining illness, significantly impacts morbidity and mortality. This study aims to compare complications arising from ventriculoperitoneal shunt (VPS) and lumbar peritoneal shunt (LPS) procedures used to manage refractory intracranial hypertension (IH) secondary to CM in HIV-infected patients. METHODS: Retrospective data were collected from January 2003 to January 2015 for HIV-infected adults diagnosed with refractory IH secondary to CM and subsequently shunted. Demographics, clinical characteristics, antiretroviral therapy, laboratory findings (including CD4 count and CSF results), CT brain scan results, shunt-related complications, and mortality were compared between VPS and LPS groups. RESULTS: This study included 83 patients, with 60 (72%) undergoing VPS and 23 (28%) receiving LPS. Mean ages were comparable between VPS (32.5) and LPS (32.2) groups (p = 0.89). Median CD4+ counts were 76 cells/µl (IQR= 30-129) in VPS versus 54 cells/µl (IQR= 31-83) in LPS (p=0.45). VPS group showed a higher mean haemoglobin of 11.5 g/dl compared to 9.9 g/dl in the LPS group (p=0.001). CT brain scans showed hydrocephalus in 55 VPS and 13 LPS patients respectively. Shunt complications were observed in 17 (28%) VPS patients versus 10 (43.5%) LPS patients (p=0.5). Patients developing shunt sepsis in the VPS group exhibited a median CD4+ count of 117 cells/µl (IQR= 76-129) versus 48 cells/µl (IQR= 31- 66) in the LPS group (p=0.03). Early shunt malfunction occurred more frequently in the LPS group compared to VPS group (p=0.044). The mean hospital stay was 6.2 days for VPS versus 5.4 days for LPS patients (p=0.9). In-hospital mortality was 6%, occurring in three VPS and two LPS patients respectively. CONCLUSION: Shunting procedures remain important surgical interventions for refractory IH secondary to HIV-related CM. However, cautious consideration is warranted for patients with CD4 counts below 200 cells/µL due to increased shunt complications. This study suggests a trend toward higher complication rates in patients undergoing LPS insertion.

Idiopathic intracranial hypertension in two twin sisters.

Idiopathic intracranial hypertension (IIH) is a condition of unknown aetiology characterised by an increase in the intracranial pressure. Familial cases of IIH are rare and not well-understood. We present two monozygotic twins who developed IIH two years apart. The case involves two monozygotic female twins developing IIH in their 50s. They presented with a history of blurry vision and headaches. The diagnosis included the neurological, radiological and ophthalmological examination, excluding other causes. Both patients received treatment with acetazolamide, successfully resolving the papilloedema and restoring a normal visual field. This case highlights the occurrence of IIH among twins presenting at similar periods, emphasising the potential genetic influence. Clinicians should alert and educate the family regarding the risk factors and potential symptoms of this condition in the unlikely occurrence that other family members are affected.

Isolated Intracranial Hypertension as a Presentation of Pediatric Lyme Borreliosis: A Case Report and Literature Review.

BACKGROUND: It is extremely rare for Lyme borreliosis to present solely with features of increased intracranial pressure. The treatment of pediatric Lyme neuroborreliosis with oral versus intravenous antibiotics remains controversial. METHODS: Case report and literature review. RESULTS: A 13-year-old male presented with five days of binocular diplopia, several weeks of headache, and a history of multiple tick bites six weeks prior. His examination showed a left eye abduction deficit and bilateral optic disc edema. Magnetic resonance imaging (MRI) of the brain with contrast showed tortuosity of the optic nerves, prominence of the optic nerve sheaths, and enhancement of the left fifth and bilateral sixth cranial nerves. Lumbar puncture showed an elevated opening pressure and a lymphocytic pleocytosis. Lyme IgM and IgG antibodies were positive in the serum and cerebrospinal fluid. The patient was treated with intravenous ceftriaxone for two days empirically followed by doxycycline by mouth for 19 days. Symptoms began improving after 48 hours. The strabismus resolved after two weeks, and the papilledema improved slowly with complete resolution at six months. CONCLUSIONS: Lyme neuroborreliosis can present as isolated intracranial hypertension in the pediatric population; it can be differentiated from idiopathic intracranial hypertension on MRI, and lumbar puncture and can be confirmed with serum antibody testing. Oral doxycycline can be considered for Lyme neuroborreliosis in children.

Persistent Elevation of Opening Pressure Despite Treatment and Symptom Resolution in Pediatric Intracranial Hypertension.

BACKGROUND: Currently no guidelines for repeating a lumbar puncture to guide management in primary intracranial hypertension (PIH) exist. METHODS: An institutional database of patients 18 years and younger followed in the institution's pediatric intracranial hypertension clinic was examined for opening pressure changes in PIH at diagnosis, before medication wean, and following medication wean, as well as to examine whether measurements at the time of diagnosis differed between those with and without disease recurrence. RESULTS: Forty-two patients were included in this study; 36% were male and the mean age at diagnosis was 11.01 years. Treatment duration averaged 9.68 months in those without recurrence and 8.5 months in those with recurrence. Average body mass index percentile of patients with disease recurrence was 83.7 and 72.1 in those without recurrence (P = 0.16). Average opening pressure values of all patients at diagnosis, prewean, and postwean was 36.53 cm H2O, 30.7 cm H2O, and 31.1 cm H2O, respectively. There was no statistically significant difference in opening pressures across these time points (P = 0.14). The change in opening pressure from diagnosis to postwean was statistically significant with a reduction of 5.18 cm H2O (P = 0.04). There was no statistical difference between change in opening pressure at diagnosis versus postwean between those with and without recurrence (P = 0.17). CONCLUSIONS: This clinical observational study suggests that mean opening pressure measurements in patients with PIH remain elevated both before and after medication wean despite papilledema resolution and patient-reported PIH symptoms. Clinically, this suggests that other features such as signs of optic disc edema and symptoms should be used to inform a clinical determination of disease recurrence and treatment course.

Management of Fallopian Canal Spontaneous CSF Leaks, Implications of Elevated Intracranial Pressure: Case Report and Systematic Review of the Literature.

OBJECTIVES: Describe the diagnosis and management of a spontaneous cerebrospinal fluid leak (sCSF-L) through the facial nerve fallopian canal and determine the role of intracranial hypertension (IH). STUDY DESIGN: Retrospective case study and systematic review of the literature. METHODS: Reviewed patient characteristics, radiographic findings, and management of the facial nerve canal CSF leak and postoperative IH. Conducted systematic literature review according to the PRISMA guidelines for surgical management and rates of IH. RESULTS: A 50-year-old female with bilateral tegmen defects and temporal encephaloceles underwent left middle cranial fossa (MCF) repair. Intraoperative CSF egressed from the temporal bone tegmen defects. Facial nerve decompression revealed CSF leak from the labyrinthine segment. A nonocclusive temporalis muscle plug was placed in the fallopian canal, and tegmen repair was completed with bone cement. A ventriculoperitoneal shunt was placed for IH. Postoperative facial nerve function and hearing were normal. A total of 20 studies met inclusion criteria with a total of 25 unique patients. Of 13 total adult cases of fallopian canal CSF leak, there is a 46% recurrence rate, and 86% of patients had documented IH when tested. CONCLUSIONS: Fallopian canal CSF leaks are rare and challenging to manage. Assessment of intracranial hypertension and CSF diversion is recommended along with MCF skull base repair to preserve facial nerve function and conductive hearing.

Correlation of the transorbital ultrasonographic optic nerve sheath diameter with intracranial pressure measured intraoperatively in infants with hydrocephalus.

OBJECTIVE: Hydrocephalus is a highly significant global public health concern. In infants, it may be associated with a potentially deleterious increase in intracranial pressure (ICP). Currently, the gold standard for accurate monitoring of ICP is an intraventricular ICP monitor, but this method is invasive and expensive. Transorbital ultrasound measurement of the optic nerve sheath diameter (ONSD) may provide a noninvasive and cost-effective alternative method for monitoring ICP. The goal of the study was to determine the extent of the correlation between ultrasonographic ONSD and ICP in infants. METHODS: A prospective observational study of 47 children with hydrocephalus aged ≤ 18 months was performed. The ONSD was measured with a transorbital ultrasound scan, while the intraventricular CSF opening pressure was assessed using a manometer during ventriculoperitoneal shunt insertion. Data were analyzed using SPSS software. The ONSD and ICP measurements were correlated, the receiver operating characteristic (ROC) curve was evaluated, and a sensitivity analysis was performed. Inferences were made using the 0.05 alpha level of significance. RESULTS: The mean age of the study cohort was 4.8 ± 4.3 months, and 93.6% of patients were infants. The mean ONSD was 4.5 ± 0.7 mm (range 2.9-6.0 mm), and the mean ICP was 19.9 ± 6.5 mm Hg (range 5.2-32.4 mm Hg). Both ONSD and ICP increased with increasing age. The Pearson correlation coefficient revealed a strong positive correlation between ONSD and ICP (r = 0.77, p < 0.001). The ONSD cutoff points were 3.2 mm, 4.0 mm, and 4.6 mm for patients with ICPs of 10 mm Hg, 15 mm Hg, and ≥ 20 mm Hg, respectively. The sensitivity of ONSD was 97.7% (area under the ROC curve 0.99), and for every 14.3-mm Hg increase in ICP, the ONSD increased by 1.0 mm holding age constant. CONCLUSIONS: ONSD has a strong positive correlation with ICP. Correspondingly, ONSD is highly sensitive in estimating ICP.

Long-term survival after primary decompressive craniectomy for severe traumatic brain injury: an observational study from 1 to 17 years.

Primary decompressive craniectomy (DC) is carried out to prevent intracranial hypertension after removal of mass lesions resulting from traumatic brain injury (TBI). While primary DC can be a life-saving intervention, significant mortality risks persist during the follow-up period. This study was undertaken to investigate the long-term survival rate and ascertain the risk factors of mortality in TBI patients who underwent primary DC. We enrolled 162 head-injured patients undergoing primary DC in this retrospective study. The primary focus was on long-term mortality, which was monitored over a range of 12 to 209 months post-TBI. We compared the clinical parameters of survivors and non-survivors, and used a multivariate logistic regression model to adjust for independent risk factors of long-term mortality. For the TBI patients who survived the initial hospitalization period following surgery, the average duration of follow-up was 106.58 ± 65.45 months. The recorded long-term survival rate of all patients was 56.2% (91/162). Multivariate logistic regression analysis revealed that age (odds ratio, 95% confidence interval = 1.12, 1.07-1.18; p < 0.01) and the status of basal cisterns (absent versus normal; odds ratio, 95% confidence interval = 9.32, 2.05-42.40; p < 0.01) were the two independent risk factors linked to long-term mortality. In conclusion, this study indicated a survival rate of 56.2% for patients subjected to primary DC for TBI, with at least a one-year follow-up. Key risk factors associated with long-term mortality were advanced age and absent basal cisterns, critical considerations for developing effective TBI management strategies.

Systemic lupus erythematosus with chronic persistent intracranial hypertension: A case report.

OBJECTIVE: The aim is to investigate the clinical characteristics of systemic lupus erythematosus with intracranial hypertension. METHODS: The clinical characteristics of one case of systemic lupus erythematosus with chronic persistent intracranial hypertension were analyzed, and related literature was reviewed by searching Medline and Wanfang databases. RESULTS: Intracranial hypertension in SLE patients may occur at the onset or during the course of the disease. Our patient was diagnosed with IH 3 years after the onset of SLE. Headache and papilledema were the most common symptoms of intracranial hypertension, followed by nausea or vomiting, vision changes, and cerebral palsy. Our patient had a headache and cranial hypertension that lasted for years, but no papilledema was found. Corticosteroid is currently the mainstay of the treatment of IIH in patients with SLE, and immunosuppressive agents, acetazolamide, intravenous mannitol and furosemide are also used. However, our patient did not respond to these treatments and presents the characteristics of chronic persistent intracranial hypertension. CONCLUSION: Systemic lupus erythematosus with intracranial hypertension is a rare manifestation of SLE, which is not completely parallel to SLE activity. Headache and papilledema were the most common presenting symptoms. Different from previous reported cases, our patient had poor response to treatments, showing chronic and persistent characteristics.

Pituitary Dysfunction in Idiopathic Intracranial Hypertension: An Analysis of 80 Patients.

BACKGROUND: Empty sella is a commonly described imaging entity in patients with idiopathic intracranial hypertension (IIH). Though menstrual and hormonal disturbances have been associated with IIH, available literature lacks systematic analysis of pituitary hormonal disturbances in IIH. More so, the contribution of empty sella in causing pituitary hormonal abnormalities in patients of IIH has not been described. We carried out this study to systematically assess the pituitary hormonal abnormalities in patients with IIH and its relation to empty sella. METHODS: Eighty treatment naïve patients of IIH were recruited as per a predefined criterion. Magnetic resonance imaging (MRI) brain with detailed sella imaging and pituitary hormonal profile were done in all patients. RESULTS: Partial empty sella was seen in 55 patients (68.8%). Hormonal abnormalities were detected in 30 patients (37.5%), reduced cortisol levels in 20%, raised prolactin levels in 13.8%, low thyroid-stimulating hormone (TSH) levels in 3.8%, hypogonadism in 1.25%, and elevated levels of gonadotropins were found in 6.25% of participants. Hormonal disturbances were independent and were not associated with the presence of empty sella (p = 0.493). CONCLUSION: Hormonal abnormalities were observed in 37.5% patients with IIH. These abnormalities did not correlate with the presence or absence of empty sella. Pituitary dysfunction appears to be subclinical in IIH and responds to intracranial pressure reduction, not requiring specific hormonal therapies.

Measurement of Optic Nerve Sheath Diameter by Computed Tomography in the Pediatric Population: Normal Values.

PURPOSE: To determine the normal values of optic nerve sheath diameter (ONSD) by computed tomography (CT) in the pediatric population. METHODS: The CT scans of pediatric patients aged 1 to 16 years who underwent brain CT for different reasons, who did not have intracranial pathology or increased intracranial pressure, and who had no pathology on CT were included in the study. Four age groups were defined with the following ranges: 1 to 2, 3 to 6, 7 to 10, and 11 to 16 years. ONSD was measured from axial CT images, 3 and 10 mm behind the optic globe. RESULTS: The normative values of ONSD measured on CT imaging in children aged 1 to 16 years were reported. The change in ONSD according to age was investigated. ONSD was found to increase with age at both levels measured. The difference was statistically significant. CONCLUSIONS: Normal values should be known to detect pathologies that may cause an increase in optic nerve diameter. The values reported in this study can serve as a reference for normal optic nerve sheath diameter in the pediatric age group. [J Pediatr Ophthalmol Strabismus. 2024;61(1):38-43.].

Optic Nerve Sheath Diameter Sonography for the Diagnosis of Intracranial Hypertension in Traumatic Brain Injury: A Systematic Review and Meta-Analysis.

OBJECTIVES: Timely diagnosis and management of elevated intracranial pressure (ICP) in patients with traumatic brain injury (TBI) can significantly reduce mortality rates. Ultrasound examination of the optic nerve sheath diameter (ONSD) is considered a potential, noninvasive, and effective method for assessing ICP. We conducted a systematic review and meta-analysis of ONSD ultrasound detection and invasive ICP monitoring methods to compare and evaluate the diagnostic accuracy of ONSD ultrasound detection methods for intracranial hypertension (IH) in patients with TBI. METHODS: We searched the Web of Science, PubMed, and Embase databases to assess the diagnostic accuracy of ONSD sonography for predicting increased ICP. The 2 authors independently extracted the collected data. Simultaneously, the QUADAS-2 tool was used to evaluate the bias risk of each study and conducted random-effects meta-analyses for the accuracy and specificity of diagnosis, and calculated pooled estimates. RESULTS: Ten studies with 512 patients were included. The diagnostic accuracy of ONSD sonography for IH was revealed as a pooled sensitivity of 0.85 (95% confidence interval [CI], 0.79-0.89) and specificity of 0.88 (95% CI, 0.80-0.93), compared with the invasive ICP monitoring standard for patients with TBI. CONCLUSIONS: ONSD sonography may be a useful method for predicting increased ICP in adult patients with TBI. Further clinical studies are required to confirm the diagnostic value of ONSD sonography.

The Relationship between Lumbar Puncture Opening Pressure and Retinal Nerve Fiber Layer Thickness in the Diagnosis of Idiopathic Intracranial Hypertension: Is a Lumbar Puncture Always Necessary?

OBJECTIVES: Idiopathic intracranial hypertension (IIH), is characterized by elevated intracranial pressure (ICP) without an identified cause. Today, lumbar puncture (LP) is the most common method used for diagnosis by measuring cerebrospinal fluid (CSF) pressure to reflect intracranial pressure. This invasive examination has significant disadvantages, such as complications and negative experiences for patients. Therefore, noninvasive methods for ICP measurement are desired. Optical coherence tomography (OCT) is widely used for the diagnosis and follow-up of IIH patients as it reflects papilledema. The aim of this study is to investigate the relationship between CSF pressure and OCT parameters and the ability of OCT in the diagnostic approach. METHODS: In our study, patients who were followed up with a diagnosis of IIH with complete neuro-ophthalmological examinations, including visual acuity (VA), visual field, and OCT imaging within 24 hours before lumbar puncture, were retrospectively evaluated. CSF pressure, visual acuity LogMAR, mean deviation of visual fields, retinal nerve fiber layer (RNFL) thickness measured by OCT, and treatment protocols were obtained from our hospital data system. RESULTS: A total of 42 eyes of 21 patients were enrolled in the study. A statistically significant positive and moderate correlation was found between CSF pressure values and average RNFL thickness ( r =0.507; P =0.001). The same relationship was demonstrated in all 4 quadrants: inferior, superior, nasal, and temporal. CONCLUSIONS: Increased peripapillary RNFL thickness in optic nerve head OCT may be correlated with increased ICP in IIH patients. A larger number of patients are needed to better understand the correlation between OCT parameters and CSF pressure in patients with IIH.

Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol.

BACKGROUND AND OBJECTIVES: Traumatic brain injury (TBI) is a major global public health problem. It is a leading cause of death and disability in children and adolescents worldwide. Although increased intracranial pressure (ICP) is common and associated with death and poor outcome after pediatric TBI, the efficacy of current ICP-based management remains controversial. We intend to provide Class I evidence testing the efficacy of a protocol based on current ICP monitor-based management vs care based on imaging and clinical examination without ICP monitoring in pediatric severe TBI. METHODS: A phase III, multicenter, parallel-group, randomized superiority trial performed in intensive care units in Central and South America to determine the impact on 6-month outcome of children aged 1-12 years with severe TBI (age-appropriate Glasgow Coma Scale score ≤8) randomized to ICP-based or non-ICP-based management. EXPECTED OUTCOMES: Primary outcome is 6-month Pediatric Quality of Life. Secondary outcomes are 3-month Pediatric Quality of Life, mortality, 3-month and 6-month Pediatric extended Glasgow Outcome Score, intensive care unit length of stay, and number of interventions focused on treating measured or suspected intracranial hypertension. DISCUSSION: This is not a study of the value of knowing the ICP in sTBI. This research question is protocol-based. We are investigating the added value of protocolized ICP management to treatment based on imaging and clinical examination in the global population of severe pediatric TBI. Demonstrating efficacy should standardize ICP monitoring in severe pediatric TBI. Alternate results should prompt reassessment of how and in which patients ICP data should be applied in neurotrauma care.