Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163774
Status:
COMPLETED
Last Update Posted:
2008-05-19
First Post:
2005-09-12
Brief Title:
Intensive Monitoring of Brain Injured Patients
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Intensive Monitoring of Brain Injured Patients Icp Monitoring Transcranial Doppler Jugular Bulb Oximetry Brain Oxygenation Brain Temperature and Microdialysis
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Analysis of cerebral blood flow CBF and oxygenation using complementary focal and global monitoring techniques will permit the delivery of more informed individualised and targeted therapy on the patient with severe head injury reduce episodes of secondary brain injury and therefore improve outcomes
Aims
To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI patients based on the results of data collected in patients post TBI
To establish the basis for further multi modality clinical trials in severely brain injured patients in the future
To improve understanding of the various secondary processes that continue to cause neuronal damage after the initial injury and therefore affect patient outcome
To proceed to the second phase of the study with the introduction of algorithms for treatment
Aims
To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI patients based on the results of data collected in patients post TBI
To establish the basis for further multi modality clinical trials in severely brain injured patients in the future
To improve understanding of the various secondary processes that continue to cause neuronal damage after the initial injury and therefore affect patient outcome
To proceed to the second phase of the study with the introduction of algorithms for treatment
Detailed Description:
The ultimate aim of this study is to improve the outcome of patients with severe head injury by reducing secondary brain injury It is hoped that this will be achieved by improving clinical management through the adoption of Best Practice monitoring measures The severe head injury population is a disparate clinical group with varying CBF derangements and complex inter-relationships between the various physiological parameters which are being measured Common protocol based therapy for all head-injured patients is simplistic and cannot fully accommodate the variations between patients or within an individual brain We believe that to improve outcome these individual derangements and patterns have to be identified and the correct therapeutic combinations fashioned on an individual basis This is not the current practice in Australia The first phase of this project was completed in March 2004 following the recruitment of ten patients These patients were intensively monitored and based on the data collected and current international literature we devised a new treatment protocol for patients with severe head injuries We anticipate that implementation of this new protocol will improve outcome
We aim to
further clarify what the above mentioned relationships between monitoring parameters are what are the most critical ones and the effect that optimisation of these parameters has on brain swelling ICP control and on clinical outcome
introduce treatment algorithmsprotocols to alter the haemodynamic parameters CPP and ICP and to optimise PbrO2
study the patients having decompressive craniectomy using these techniques where possible
compare patient outcomes to previous outcome studies at the Alfred Hospital
We aim to
further clarify what the above mentioned relationships between monitoring parameters are what are the most critical ones and the effect that optimisation of these parameters has on brain swelling ICP control and on clinical outcome
introduce treatment algorithmsprotocols to alter the haemodynamic parameters CPP and ICP and to optimise PbrO2
study the patients having decompressive craniectomy using these techniques where possible
compare patient outcomes to previous outcome studies at the Alfred Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None