Skip to main content
OpenTrials
Completed

NCT Number: NCT06423469

Noninvasive Intracranial Pressure Waveforms Assessment 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidade Federal do Amazonas, Manaus, Amazonas, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. In-hospital mortality

    Time frame: One month

    Is in-hospital mortality correlated with poorer brain4care biometrics?

Secondary outcomes

  1. Morbidity

    Time frame: Six months

    Is morbidity correlated with poorer brain4care biometrics?

Other outcomes

  1. Correlation with invasive information

    Time frame: Fifteen days

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

Sponsors and collaborators

Lead sponsor

Sergio Brasil, MD

Other

Collaborators

  • Braincare USA Corp

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.