Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury

NCT06423469 | Completed

• 1 other identifier: 39348920.1.1001.0068
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 4

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.

Conditions

Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Is in-hospital mortality correlated with poorer brain4care biometrics?

  One month

Secondary Outcomes (1)

• Morbidity

  Six months

Other Outcomes (1)

• Correlation with invasive information

  Fifteen days

Study Arms (1)

TBI patients

TBI patients to be monitored daily with the brain4care system for fifteen days

Device: Noninvasive ICP monitoring

Interventions

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.

TBI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sergio Brasil, MD: lead
• Braincare USA Corp: collaborator

Study Sites (4)

Universidade Federal do Amazonas

Manaus, Amazonas, 05403000, Brazil

Location

Hospital João XXIII

Belo Horizonte, Minas Gerais, 05403000, Brazil

Location

Hospital de Emergência e Trauma Senador Humberto Lucena

João Pessoa, Paraíba, 05403000, Brazil

Location

Universidade de São Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (5)

• 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.

  PMID: 38352556 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.

  PMID: 26690122 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.

  PMID: 35332426 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.

  PMID: 38355918 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.

  PMID: 34945774 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: February 1, 2020
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

BR (4)