Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Braincare USA Corp | INDUSTRY |
Not provided
Not provided
Not provided
In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. One of the main causes of coma is intracranial hypertension (IH), with traumatic brain injuries (TBI) and cerebral hemorrhages being the major contributors to its development. IH increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. Clinical studies show that adequate intracranial pressure (ICP) control in TBI patients reduces mortality and increases functionality. Unfortunately, the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull, and its perforation is required for this purpose. Several studies have attempted to identify noninvasive solutions for ICP monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. Recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. In vivo studies have identified excellent qualitative correlation with catheter ICP recordings. However, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. Therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI patients | TBI patients to be monitored daily with the brain4care system for fifteen days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive ICP monitoring | Device | The brain4care system is a FDA approved noninvasive device for surrogate intracranial pressure monitoring. Serial monitoring sessions were performed in included patients. Information recorded was for study purposes only and did not affect any therapy planned for the attending teams. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Is in-hospital mortality correlated with poorer brain4care biometrics? | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Is morbidity correlated with poorer brain4care biometrics? | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with invasive information | Are brain4care biometrics correlated with invasive intracranial pressure provided by ventricular catheters or parenchymal probes? | Fifteen days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients of any gender, older than 18 years, with very acute moderate or severe TBI will be included just after stabilization and any surgical evacuation procedure performed.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Amazonas | Manaus | Amazonas | 05403000 | Brazil | ||
| Hospital João XXIII |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38352556 | Background | Gulamali F, Jayaraman P, Sawant AS, Desman J, Fox B, Chang A, Soong BY, Arivazaghan N, Reynolds AS, Duong SQ, Vaid A, Kovatch P, Freeman R, Hofer IS, Sakhuja A, Dangayach NS, Reich DS, Charney AW, Nadkarni GN. Derivation, External Validation and Clinical Implications of a deep learning approach for intracranial pressure estimation using non-cranial waveform measurements. medRxiv [Preprint]. 2024 Jan 30:2024.01.30.24301974. doi: 10.1101/2024.01.30.24301974. | |
| 26690122 |
Not provided
Not provided
Possibly some anonymous data can be shared with other researchers upon reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Belo Horizonte |
| Minas Gerais |
| 05403000 |
| Brazil |
| Hospital de Emergência e Trauma Senador Humberto Lucena | João Pessoa | Paraíba | 05403000 | Brazil |
| Universidade de São Paulo | São Paulo | São Paulo | 05403000 | Brazil |
| Background |
| Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146. |
| 35332426 | Background | de Moraes FM, Rocha E, Barros FCD, Freitas FGR, Miranda M, Valiente RA, de Andrade JBC, Neto FEAC, Silva GS. Waveform Morphology as a Surrogate for ICP Monitoring: A Comparison Between an Invasive and a Noninvasive Method. Neurocrit Care. 2022 Aug;37(1):219-227. doi: 10.1007/s12028-022-01477-4. Epub 2022 Mar 24. |
| 38355918 | Background | de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Aug;38(4):773-782. doi: 10.1007/s10877-023-01120-3. Epub 2024 Feb 14. |
| 34945774 | Background | Brasil S, Solla DJF, Nogueira RC, Teixeira MJ, Malbouisson LMS, Paiva WDS. A Novel Noninvasive Technique for Intracranial Pressure Waveform Monitoring in Critical Care. J Pers Med. 2021 Dec 5;11(12):1302. doi: 10.3390/jpm11121302. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |