Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience

NCT ID: NCT03721003

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-30

Brief Summary

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.

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

Conditions

Head Injury Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ICP monitoring

4- Use the Touhy needle to tunnel under the scalp from the Burr Hole site to the desired MICROSENSOR exit site.

5- Place the tip of the MICROSENSOR in the Parenchyma through the puncture in the Dura

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mosab Samir

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IPMISTBISCE

Identifier Type: -

Identifier Source: org_study_id