Determining the effect of intracranial pressure monitoring catheter employment on prognosis of severe head trauma patient in Al Zahra hospital
Design
Participants in the study were randomly divided into two groups of clinical examination and CT scan (control group) and catheter (intervention group) based on the case records.
The sample size was considered as 10 in each group.
Settings and conduct
In the ICU, ICP will be continuously monitored and, if pressure is higher than 22 mmHg, treatment will be start in accordance with the fourth edition of the Guide for the treatment of severe brain injury. Patients in this group will be screened for surgical site infection and meningitis (in case of clinical symptoms).
In the control group, a clinical examination and CT scan will be performed at specific intervals and, in the case of a change in the clinical or radiological status of patients, appropriate traetment will be taken based on the fourth edition of the Guide for the treatment of severe brain injury.
Participants/Inclusion and exclusion criteria
Among all patients referred to our trauma center those who met the criteria for ICP monitoring according to the Guidelines for the Management of Severe Traumatic Brain Injury (4th edition), were enrolled.
Intervention groups
Intervention group: After transferring the patient into the operating room and under general anesthesia, the Spiegelberg Probe 3PN catheter will enter the brain through a hole in the frontal region of skull.
Control group: Patients with severe brain trauma undergoing periodic clinical examination and control CT scans.
Main outcome variables
Glasgow outcome scale extended
General information
Reason for update
Acronym
ICPmo
IRCT registration information
IRCT registration number:IRCT20180813040788N1
Registration date:2019-08-29, 1398/06/07
Registration timing:retrospective
Last update:2019-08-29, 1398/06/07
Update count:0
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Saeed Sattaei Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
saeedmokhtari367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2019-01-05, 1397/10/15
Scientific title
Evaluation of effect of intracranial pressure monitoring catheter employment on prognosis of severe head trauma patient in Al Zahra hospital
Public title
ICP Monitoring
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with consciousness levels of 3 to 8 (based on GCS criteria) and abnormal brain CT scans (including bleeding, cantogens, edema, brain hernia symptoms, or compression of brain cytars) that can be rescued, and patients with a level of consciousness 3 to 8 (based on GCS criteria) and normal brain CT scan older than 40 years of age, systolic blood pressure less than 90 mm Hg, or abnormal motor status in a clinical examination.
Exclusion criteria:
Patients who are reluctant to continue studying are excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
10
Randomization (investigator's opinion)
Randomized
Randomization description
the patients were randomly allocated with proper statistics soft wares into two groups on patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Avenue Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.mui.med.REC.1397.036
Health conditions studied
1
Description of health condition studied
Intracranial injury
ICD-10 code
S06.0
ICD-10 code description
Concussion
2
Description of health condition studied
Intracranial injury
ICD-10 code
S06.1
ICD-10 code description
Traumatic cerebral edema
3
Description of health condition studied
Intracranial injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
4
Description of health condition studied
Intracranial injury
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
5
Description of health condition studied
Intracranial injury
ICD-10 code
S06.4
ICD-10 code description
Epidural hemorrhage
6
Description of health condition studied
Intracranial injury
ICD-10 code
S06.5
ICD-10 code description
Traumatic subdural hemorrhage
7
Description of health condition studied
Intracranial injury
ICD-10 code
S06.6
ICD-10 code description
Traumatic subarachnoid hemorrhage
8
Description of health condition studied
Intracranial injury
ICD-10 code
S06.8
ICD-10 code description
Other specified intracranial injuries
9
Description of health condition studied
Intracranial injury
ICD-10 code
S06.9
ICD-10 code description
Unspecified intracranial injury
Primary outcomes
1
Description
Prognosis of patients with severe brain trauma
Timepoint
Determination of prognosis of patients with severe traumatic brain injury on discharge
Method of measurement
The Glasgow Outcome Scale Extended (GOS-E)
Secondary outcomes
1
Description
Surgical site infection
Timepoint
During the hospitalization
Method of measurement
Clinical signs and symptoms and Cultivation of the wound site
2
Description
Meningitis
Timepoint
During the hospitalization
Method of measurement
Clinical signs and symptoms and cerebrospinal fluid culture
Intervention groups
1
Description
Intervention group: Patients in this group will receive intracranial pressure monitoring catheter (Spiegelberg probe 3PN) and intracranial pressure lowering treatments will be performed based on intracranial pressure value according to the study protocol.
Category
Early detection
2
Description
Control group: In these patients intracranial pressure lowering treatments will be performed according to neurological examination and serial imaging according to the study protocol.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Medical Center
Full name of responsible person
Saeed Sattaei Mokhtari
Street address
Safeh Boulevard, Al-Zahra Medical Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
saeedmokhtari367@gmail.com
Web page address
http://alzahra.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Sattaei Mokhtari
Street address
Safeh Boulevard, Al-Zahra Medical Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
saeedmokhtari367@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Sattaei Mokhtari
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Sufeh Boulevard Al Zahra Medical Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
saeedmokhtari367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Sattaei Mokhtari
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Sufeh Boulevard Al Zahra Medical Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
saeedmokhtari367@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Sattaei Mokhtari
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Sufeh Boulevard Al Zahra Medical Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
saeedmokhtari367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data could be shared after Unidentifiable people.
When the data will become available and for how long
6 months after publishing results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Via email at saeedmokhtari367@gmail.com
From where data/document is obtainable
Via email at saeedmokhtari367@gmail.com
What processes are involved for a request to access data/document