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Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury

A Multicenter Observational Cohort for the Determination of Noninvasive Intracranial Pressure Waveforms Role in Traumatic Brain Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06423469
Enrollment
345
Registered
2024-05-21
Start date
2020-02-01
Completion date
2024-04-30
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, intracranial pressure, intracranial compliance, intracranial pressure waveforms, neurological noninvasive monitoring

Brief summary

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.

Interventions

DEVICENoninvasive ICP monitoring

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.

Sponsors

Braincare USA Corp
CollaboratorINDUSTRY
Sergio Brasil, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Moderate to severe traumatic brain injury with less than 24 hours.

Exclusion criteria

* Primary decompressive craniectomy * Brain death signs at admission * Severe hemodynamic instability

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortalityOne monthIs in-hospital mortality correlated with poorer brain4care biometrics?

Secondary

MeasureTime frameDescription
MorbiditySix monthsIs morbidity correlated with poorer brain4care biometrics?

Other

MeasureTime frameDescription
Correlation with invasive informationFifteen daysAre brain4care biometrics correlated with invasive intracranial pressure provided by ventricular catheters or parenchymal probes?

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026