Objective: To determine the effect of APRV on intracranial pressure and cerebral oxygenation of patients with traumatic brain injuries. Study design: randomized clinical trial in two groups. Study population: patients with traumatic brain injury. Inclusion criteria: age between 18 and 70 years; patient with traumatic brain injury who are under intubation and mechanical ventilation with SIMV mode; stable hemodynamic (MAP > 70 mm Hg at least 30 minutes before the start of the study); Glasgow Coma Scale <9. Exclusion criteria: unstable hemodynamic (MAP <70); CPP <60 mm Hg; intracranial pressure > 25 mmHg. Sample size: 20 patients in each group. Intervention: in Intervention group, apply the APRV mode for up to half an hour, compared with SIMV in control group and then variables (ICP, CPP, PaO2, Paco2, P/F ratio, MAP) are measured. Expected outcome: APRV can be safely used in TBI patients without increasing ICP and it improve hypoxemia.
General information
Acronym
Airway Pressure Release Ventilation
IRCT registration information
IRCT registration number:IRCT2015070623104N1
Registration date:2016-05-05, 1395/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Aliyeh Pasandideh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3733 1337
Email address
pasandidea1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of airway pressure release ventilation on intracranial pressure and oxygenation of patients with traumatic brain injuries
Public title
Effect of mechanical ventilation on intracranial pressure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 70 years; traumatic brain injuries who are intubated and under mechanical ventilation with SIMV mode; stable hemodynamic (MAP more than 70 mm Hg for at least 30 minutes before the start of the study); Glasgow Coma Scale <9 ; no history of chronic obstructive pulmonary disease (COPD); ratio of arterial oxygen to inspired oxygen fraction <400; having intraventricular catheter for ICP monitoring; ICP > 10 mm Hg. Exclusion criteria: unstable hemodynamic (MAP <70); CPP <60 mmHg; ICP > 25 mmHg; pneumothorax
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
Quraishi building, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2015-07-04, 1394/04/13
Ethics committee reference number
IR.MUMS.IEC.1394.249
Health conditions studied
1
Description of health condition studied
traumatic brain injuries
ICD-10 code
s06.2, s06
ICD-10 code description
Other intracranial injuries, Intracranial injury with prolonged coma,Traumatic subarachnoid haemorrhage,Traumatic subdural haemorrhage,Diffuse brain injury,Focal brain injury,Epidural haemorrhage,
Primary outcomes
1
Description
Intracranial pressure
Timepoint
Before and half an hour after the intervention
Method of measurement
Intraventricular catheter -mmHg
2
Description
Pressure of arterial oxygen
Timepoint
Before and half an hour after the intervention
Method of measurement
mmHg
3
Description
Arterial oxygen saturation
Timepoint
Before and half an hour after the intervention
Method of measurement
Pulseoxymetry- percent
4
Description
Ratio of arterial oxygen to inspired oxygen fraction
Timepoint
Before and half an hour after the intervention
Method of measurement
number
Secondary outcomes
1
Description
Mean arterial pressure
Timepoint
Before and after half an hour the intervention.
Method of measurement
Barometer- mmHg
2
Description
Cerebral perfusion pressure
Timepoint
Before and after half an hour the intervention
Method of measurement
Calculation formula- mmHg
Intervention groups
1
Description
Intervention of this research is a ventilation mode that is called Airway Pressure Release Ventilation that applied for half an hour. This is an inverse ratio mode that airway pressure of patient, between high pressure and low pressure is fluctuated. In this intervention, the duration of high pressure is 5 second and duration of low pressure is 1 second. The high-level pressure based on the mean airway pressure of patient.
Category
Other
2
Description
In the control group patients are ventilated with SIMV mode for half an hour.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Trauma Center of Mashhad( Shahid Kamiyab hospital)- Neurosurgery Intensive Care Unit
Full name of responsible person
Aliyeh Pasandideh
Street address
Fadaeyan Eslam street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, research assisstance
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Quraishi building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, research assisstance
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
Mashhad University of Medical Sciences
Full name of responsible person
Javad Malekzadeh
Position
master of nursing science
Other areas of specialty/work
Street address
Mashhad Nursing & Midwifery School-West Ebn-e-Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 5511
Fax
Email
malekzadehj@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Javad malekzadeh
Position
master of nursing science
Other areas of specialty/work
Street address
Mashhad Nursing & Midwifery School-West Ebn-e-Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
malekzadehj@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aliyeh pasandideh
Position
student
Other areas of specialty/work
Street address
Nursing and Midwifery school, West Ebn-e-Sina street
City
Mashhad
Postal code
Phone
+98 51 3733 1337
Fax
Email
pasandidea1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)