Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02507999
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2015-07-22
Brief Title:
Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients - A Prospective Blinded Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Goal directed therapy GDT is a technique which employs a non-invasive cardiac output monitoring NICOM device to guide management of circulating blood volume and blood pressure during procedures The purpose of this study is to determine whether the use of goal-directed therapy to optimize blood volume and cardiac output during the procedure can improve the outcome of patients undergoing endovascular treatment of a brain aneurysm
Detailed Description:
Subarachnoid hemorrhage SAH as a result of ruptured intracranial cerebral aneurysms is a life threatening condition with an estimated incidence of 6-10 cases per 100000 persons per year Endovascular coil emobolization of the aneurysm is performed to isolate the aneurysm and reduce the risk of re-bleeding Unfortunately despite timely and successful intervention approximate 25 of post-coiling patients suffer immediate andor long-term injury including death as a result of intracranial bleeding This is mainly a consequence of subarachnoid hemorrhage-related complications especially cerebral vasospasm Angiographic vasospasm and symptomatic vasospasm occur in 30-70 and 20-30 of SAH patients respectively Goal-directed therapy GDT provides a means to assess and manage circulating volume and cardiac output In this study the investigators would investigate the use of GDT during aneurysm coiling procedures can improve the clinical course of these patients
This will be a blinded randomized pilot study to compare clinical outcomes for endovascular coiling patients allocated to one of two treatments GDT or non-GDT Randomization consented patients will be randomized into GDT or non-GDT groups in 11 ratio The attending anesthesiologists will not be blinded because of the nature of the intervention However surgeons patients outcomes assessors will be blinded as to the treatment intervention
In all patients an arterial catheter routinely used in these patients will be inserted and connected to the Flotrac Edward Lifesciences After transferring the patients into the angiogram suite routine monitoring such as pulse oximetry electrocardiography non-invasive blood pressure monitoring end-tidal CO2 and temperature probe will be attached to the patients Anesthesia will be conducted in the standard fashion Patients will be randomized into two groups in 11 ratio GDT or non-GDT therapy
GDT group the attending anesthesiologist will use the data obtained from the Flotrac to manage fluid and hemodynamics during the procedure following the prescribed treatment algorithm The treatment interventions will start on induction of anesthesia and continue until the patients are extubated or transferred back to intensive care unit with mechanical ventilation
Non-GDT group Flotrac will be connected but the machine values will be blinded to the anesthesiologist and interventionist The screens of the Flotrac will be covered by opaque plastic bag and the alarms will be turned off The attending anesthesiologist will make clinical decisions regarding the management of fluids and hemodynamics based on current individual routine practices
This will be a blinded randomized pilot study to compare clinical outcomes for endovascular coiling patients allocated to one of two treatments GDT or non-GDT Randomization consented patients will be randomized into GDT or non-GDT groups in 11 ratio The attending anesthesiologists will not be blinded because of the nature of the intervention However surgeons patients outcomes assessors will be blinded as to the treatment intervention
In all patients an arterial catheter routinely used in these patients will be inserted and connected to the Flotrac Edward Lifesciences After transferring the patients into the angiogram suite routine monitoring such as pulse oximetry electrocardiography non-invasive blood pressure monitoring end-tidal CO2 and temperature probe will be attached to the patients Anesthesia will be conducted in the standard fashion Patients will be randomized into two groups in 11 ratio GDT or non-GDT therapy
GDT group the attending anesthesiologist will use the data obtained from the Flotrac to manage fluid and hemodynamics during the procedure following the prescribed treatment algorithm The treatment interventions will start on induction of anesthesia and continue until the patients are extubated or transferred back to intensive care unit with mechanical ventilation
Non-GDT group Flotrac will be connected but the machine values will be blinded to the anesthesiologist and interventionist The screens of the Flotrac will be covered by opaque plastic bag and the alarms will be turned off The attending anesthesiologist will make clinical decisions regarding the management of fluids and hemodynamics based on current individual routine practices
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