Evaluation and comparison of intracranial pressure in the patients with supra tentorial tumor According to different the positive end expiatory pressure applied during tumor surgery
Aim: The aim of this study is the evaluation of Positive End Expiratory Pressure (PEEP) effect on intracranial pressure (ICP) in the neurosurgical patients with the supratentorial tumor.
Method and material: In this clinical trial study, we will be choose 66 patients with the supratentorial tumor who have the indication for the neurosurgical procedure,
Inclusion criteria: neurosurgical patients with supratentorial tumor; Ages 18 to 60 years; Without having hypertension or diabetes; No history of stroke or heart failure.
Exclusion criteria: patients with lung diseases such as asthma and chronic obstructive pulmonary disease; Brain shifts to the more than 5 mm from the mid line; Severe hydrocephalus; Loss of consciousness; Closed brain solcus, severe headache; Nausea and vomiting.
Afterward patients will be divide randomly into 3 groups in PEEP different levels applying that will be include: group A in PEEP=0 cmH2O, group B in PEEP=5 cmH2O and group C in PEEP=10 cmH2O. we will be measure systolic and diastolic blood pressure, mean arterial pressure (MAP) and pulse rate of all patients at different times, also we will be evaluate the consistency of the dura mater before and after dura mater resection. All data and information will be collect and analyze with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041912782N14
Registration date:2017-05-15, 1396/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-15, 1396/02/25
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical sciences.
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of intracranial pressure in the patients with supra tentorial tumor According to different the positive end expiatory pressure applied during tumor surgery
Public title
Effect of Positive End Expiratory Pressure on intracranial pressure in the neurosurgical patients with the supratentorial tumor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: neurosurgical patients with supratentorial tumor; Ages 18 to 60 years; Without having hypertension or diabetes; No history of stroke or heart failure.
Exclusion criteria: patients with lung diseases such as asthma and chronic obstructive pulmonary disease; Brain shifts to the more than 5 mm from the mid line; Severe hydrocephalus; Loss of consciousness; Closed brain solcus, severe headache; Nausea and vomiting.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Isfahan University of Medical sciences, Hezar Jareeb street,Isfahan, Iran
City
Isfahan
Postal code
8174675731
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUI.REC.1395.30320
Health conditions studied
1
Description of health condition studied
supratentorial
ICD-10 code
D33.0
ICD-10 code description
Benign neoplasm: Brain, supratentorial
Primary outcomes
1
Description
Intracranial pressure
Timepoint
Before and after the intervention.
Method of measurement
Touching the dura mater
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group 1: patients who have 0 cmH2O Positive End Expiratory Pressure
Category
Treatment - Devices
2
Description
The intervention group 2: patients who have 5 cmH2O Positive End Expiratory Pressure
Category
Treatment - Devices
3
Description
The intervention group 3: patients who have 10 cmH2O Positive End Expiratory Pressure
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Dr Mehrdad Masoudifar
Street address
Alzahra hospital, Alzahra street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Vahid Salimi
Position
General physician
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 316680048
Fax
Email
vahid.salimi79@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehrdad Masoudifar
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3625 5555
Fax
Email
masoudifar@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for Research/Master of Science
Other areas of specialty/work
Street address
Research office , Al Zahra hospital, Al zahra street, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 313132651574
Fax
Email
Mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)