Head Injury TraumaNCT03721003
Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience
An observational study of Head Injury Trauma, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head Injury Trauma
- What is being tested?
- ICP monitoring
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age >18
- GCS < 8
- patient with severe brain insult ( Marshall class II to IV)
- patients admitted within 24 hours from the trauma time
Who cannot join
- Patients admitted for surgery (ex; surgical EDH) .
- patient diagnosed as brain death
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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.
- 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
- Being tested
- ICP monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP monitoringDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosab Samir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721003
- Sponsor's protocol ID
- IPMISTBISCE
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Centre Experience
- ClinicalTrials.gov ID
- NCT03721003
- Acronym / sponsor ID
- IPMISTBISCE
- Conditions
- Head Injury Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age >18
- GCS < 8
- patient with severe brain insult ( Marshall class II to IV)
- patients admitted within 24 hours from the trauma time
Key exclusion criteria (2 listed)
- Patients admitted for surgery (ex; surgical EDH) .
- patient diagnosed as brain death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP monitoring4- 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 | Device | – |
Primary outcome
analyse role of ICP monitoring of patient with diffuse traumatic brain injury
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Head Injury Trauma
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury Trauma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analyse role of ICP monitoring of patient with diffuse traumatic brain injury (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.