Non-Invasive Intracranial Pressure Monitoring in Traumatic Brain Injury Patients
nICP
Brain Injuries, Traumatic+6
+ Brain Diseases
+ Brain Injuries
Basic Science Study
Summary
Study start date: January 20, 2020
Actual date on which the first participant was enrolled.Traumatic brain injury (TBI) is a leading cause of death and disability, especially in individuals under 40. A key aspect of managing severe TBI involves monitoring intracranial pressure (ICP), which is the pressure within the skull. High ICP can lead to further brain damage, resulting in increased disability or even death. Currently, ICP measurement involves placing a sensor into the brain tissue, a procedure that carries risks of infection and bleeding, and can only be performed by a neurosurgeon. This study aims to develop a non-invasive method to measure ICP, reducing risks, permitting monitoring outside the hospital, and potentially expanding its use to other conditions like stroke or brain tumors. The proposed non-invasive ICP monitor works by shining a harmless light into the brain through the skull. A sensor attached to the forehead records optical signals known as photoplethysmography (PPG), which are related to changes in ICP. This pilot study aims to create the first clinical database of these signals in intensive care patients. The collected data will help generate advanced algorithms and machine learning models to translate optical signals into absolute ICP measurements. The study's primary outcome is to evaluate the agreement between the non-invasive ICP measurements and traditional invasive methods.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location