Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT06423469
• Lead Sponsor: Sergio Brasil, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	One month	Is in-hospital mortality correlated with poorer brain4care biometrics?

Secondary Outcome Measures

Name	Time	Method
Morbidity	Six months	Is morbidity correlated with poorer brain4care biometrics?