NCT03721003

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

September 29, 2018

Last Update Submit

October 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age \>18
  • GCS \< 8
  • patient with severe brain insult ( Marshall class II to IV)
  • patients admitted within 24 hours from the trauma time

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 29, 2018

First Posted

October 26, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

December 30, 2021

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share