Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience

Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Centre Experience

Intracranial pressure (ICP) is defined as the pressure inside the skull, and therefore, the pressure inside the brain tissue and the cerebrospinal fluid (CSF). The relationship between CSF and intracranial blood volumes is described by the Monroe Kellie doctrine; because the brain is incompressible, when the skull is intact, the sum of the volumes of brain, CSF, and intracranial blood is constant.

Study Overview

• Status: Unknown
• Conditions: Head Injury Trauma
• Intervention / Treatment: Device: ICP monitoring

Detailed Description

ICP >15 mmHg is considered to be elevated, and this is considered an important cause of secondary injury leading to irreversible brain injury and death. ICP monitoring is used in a number of conditions; traumatic brain injury, intracerebral haemorrhage, subarachnoid haemorrhage, hydrocephalus, malignant infarction, cerebral oedema, CNS infections, hepatic encephalopathy, to name a few, and in all of these conditions ICP monitoring in the light of other parameters can influence management for better outcomes.

There are 4 ways to monitor intracranial pressure:

1. An intra-parenchymal method, the catheter is placed into the brain parenchyma through a burr hole; it has a lower complication rate, lower infection rate, and no chance of catheter occlusion or leakage. Neurological injury is minimized because of the small diameter of the probe. In addition, malposition of the transducer has less impact on errors of measurement.
2. An intra-ventricular method, the catheter is placed into one of the ventricles (lat. Ventricle). The catheter can also be used for therapeutic CSF drainage and for administration of drugs.
3. Subdural method, this method is used if monitoring needs to be done right away. A hollow screw is inserted through a burr hole and placed through the Dura mater.
4. An epidural sensor is inserted between the skull and dural tissue. This procedure is less invasive than other methods.

ICP monitoring methods is associated with a number of complications. These include risk of infection, haemorrhage, obstruction, difficulty in placement, malposition, etc.

The use of an ICP monitor is associated with significantly lower mortality when compared with patients treated without an ICP monitor

• Study Type: Observational
• Enrollment (Anticipated): 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

history of present illness will be taken clinical assesment will be done ct brain will be done after that ICP monitor will be applied

Description

Inclusion Criteria:

1. Age >18
2. GCS < 8
3. patient with severe brain insult ( Marshall class II to IV)
4. patients admitted within 24 hours from the trauma time

Exclusion Criteria:

1. Patients admitted for surgery (ex; surgical EDH) .
2. patient diagnosed as brain death

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analyse role of ICP monitoring of patient with diffuse traumatic brain injury	study the significance of application of ICP monitor on outcome of patients with diffuse traumatic brain injury using glascow coma scale The Glasgow Coma Scale (GCS) is a neurological scale which aims to give a reliable and objective way of recording the conscious state of a person for initial as well as subsequent assessment. A patient is assessed against the criteria of the scale, and the resulting points give a patient score between 3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)	one year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: September 29, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (ACTUAL): October 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: IPMISTBISCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No