## Protocol Section
### Identification Module
**NCT ID:** NCT06423469

**Brief Title:** Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury

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

#### Organization Study ID Info
**ID:** 39348920.1.1001.0068
#### Organization
**Class:** OTHER
**Full Name:** University of Sao Paulo
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-30

**Type:** ACTUAL

#### Start Date
**Date:** 2020-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sergio Brasil, MD

#### Responsible Party

**Investigator Affiliation:** University of Sao Paulo

**Investigator Full Name:** Sergio Brasil, MD

**Investigator Title:** MD. PhD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Traumatic Brain Injury

**Keywords:**

- traumatic brain injury

- intracranial pressure

- intracranial compliance

- intracranial pressure waveforms

- neurological noninvasive monitoring

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 345

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Outcomes Module

#### Other Outcomes

**Description:** Are brain4care biometrics correlated with invasive intracranial pressure provided by ventricular catheters or parenchymal probes?

**Measure:** Correlation with invasive information

**Time Frame:** Fifteen days

#### Primary Outcomes

**Description:** Is in-hospital mortality correlated with poorer brain4care biometrics?

**Measure:** In-hospital mortality

**Time Frame:** One month

#### Secondary Outcomes

**Description:** Is morbidity correlated with poorer brain4care biometrics?

**Measure:** Morbidity

**Time Frame:** Six months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### IPD Sharing Statement Module

**Description:** Possibly some anonymous data can be shared with other researchers upon reasonable request.

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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.

**PMID:** 38355918

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: HIGH

- As Found: Traumatic Brain Injury

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

- ID: D000070642

- Term: Brain Injuries, Traumatic

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-31
