Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03721003
Collaborator
(none)
32
35.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Centre Experience
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Dec 30, 2021

Outcome Measures

Primary Outcome Measures

  1. analyse role of ICP monitoring of patient with diffuse traumatic brain injury [one year]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mosab Samir, doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT03721003
Other Study ID Numbers:
  • IPMISTBISCE
First Posted:
Oct 26, 2018
Last Update Posted:
Oct 26, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2018