Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT03721003
Status:
UNKNOWN
Last Update Posted:
2018-10-26
First Post:
2018-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Centre Experience
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: