The aim of this study is survey the effect of airway pressure release ventilation mode on intracranial pressure, oxygenation and hemodynamic of patients with traumatic brain injury. This study is a Triple-blind (patient, data collector and analyzer) randomized clinical trial with two-groups. 50 patients 18-70 years old with brain injuries and need ventilator, with GCS <9 and without COPD are divided into two groups. In control group at least one hour after SIMV / PSV mode, all intracranial pressure variables and hemodynamic and oxygenation parameters will be measured by the researcher. After an hour of ventilation in SIMV / PSV mode, again all variables will be measured at the same condition. In experimental group, at least one hour after SIMV / PSV mode, all the above variables, will be measured and then patient ventilate for an hour with APRV mode. At the end of an hour, then all mentioned variables will be measured at the same condition.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021426558N1
Registration date:2016-06-10, 1395/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Maryam Safari Bidokhti
Name of organization / entity
Shahrood University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 6871
Email address
safarim2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness Airway pressure release ventilation mode on hemodynamics and oxygenation intracranial pressure and cerebral trauma patients than routine fashion ventilation (Synchronized intermittent mandatory ventilation)
Public title
The influence of some kind of ventilation on the heart and brain and lungs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 70 years; TBI patients who underwent intubation and mechanical ventilation mode SIMV / PSV (due to intervention of the kind of pressure that fashion should be a routine fashion is also a kind of pressure) are hemodynamic stability (MAP> 70 mm Hg and lasting at least 30 minutes before the start of the study); ALI according to the anesthesiologist and intensive care; GCS <9; lack of chronic obstructive pulmonary disease (COPD), according to the anesthesiologist and intensive care, having Vntryklvstvmy catheters for intracranial pressure monitoring, the patient is RASS of -3.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
University of Medical Sciences shahrood
Street address
Shahrood- Hafte-Tir Square
City
Shahrood
Postal code
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IR.SHMU.REC.1394.184
Health conditions studied
1
Description of health condition studied
head Trauma
ICD-10 code
S09
ICD-10 code description
Other and unspecified injuries of head
Primary outcomes
1
Description
Oxygenation
Timepoint
Baseline, one hour later
Method of measurement
Arterial blood samples
2
Description
Increased Intracranial Pressure
Timepoint
Baseline, one hour later
Method of measurement
ventriclostomy
3
Description
Hemodynamic
Timepoint
Baseline, one hour later
Method of measurement
Blood pressure measurement
Secondary outcomes
1
Description
blood pressure
Timepoint
Baseline, one hour later
Method of measurement
Blood pressure measurement
2
Description
intracranial pressure
Timepoint
Baseline, one hour later
Method of measurement
ventricolostomy
Intervention groups
1
Description
Use Airway pressure release ventilation (APRV) mode for an hour in the intervention group
Category
Treatment - Other
2
Description
Use Synchronized intermittent mandatory ventilation (SIMV) mode for an hour in the control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamyab Hospital
Full name of responsible person
Maryam Safari Bidokhti
Street address
Fadaeeian of Isalam Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Maryam Safari Bidokhti
Street address
Sento Road
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Medical Sciences Shahrood
Full name of responsible person
Dr. Mohamad hasan Emamian
Street address
Shahrood, Hafte-Tir Square
City
Shahrood
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 and Technology of Medical Sciences Shahrood
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
Shahrood University of Medical Sciences
Full name of responsible person
Maryam Safari Beidokhti
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
16 Soroush, Vacil Abad Street
City
Mashhad
Postal code
00989188867973
Phone
+98 51 3608 6871
Fax
Email
safarim2@mums.ac.irmaryamners@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Hoseen Bagheri
Position
phd
Other areas of specialty/work
Street address
haft tir sq.
City
shahrood
Postal code
Phone
+98 912 273 3369
Fax
Email
baghe_h1@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Maryam Safari Beidokhti
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
16 Soroush, Vacil Abad Street
City
Mashhad
Postal code
00989188867973
Phone
+98 51 3608 6871
Fax
Email
safarim2@mums.ac.irmaryamners@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)