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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Actual): 345

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Is in-hospital mortality correlated with poorer brain4care biometrics?	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Is morbidity correlated with poorer brain4care biometrics?	Six months

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sergio Brasil, MD

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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 Feb 14. doi: 10.1007/s10877-023-01120-3. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: intracranial pressure; traumatic brain injury; intracranial compliance; intracranial pressure waveforms; neurological noninvasive monitoring
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 39348920.1.1001.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Possibly some anonymous data can be shared with other researchers upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No