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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.
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 100,000 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 and/or 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 1:1 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 1:1 ratio: GDT or non-GDT therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal Directed Therapy - Flotrac Use Arm | Experimental | This arm will employ the use of the Flotrac device to monitor cardiac output, cardiac index, stroke volume, stroke volume variation, and blood pressure management. |
|
| Non-Goal Directed Therapy | No Intervention | In this arm, patients will have the Flotrac machine attached to their arterial catheter but the screen that displays the monitor readings will be covered and machine alarms will be turned off. The anesthesiologist will not be aware of the Flotrac monitor readings. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flotrac | Device | Flotrac guided intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcomes of cerebral vasospasm, stroke and death | To determine if the use of the Flotrac device during surgery is able to decrease the morbidity and mortality rates for 30 days following surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcomes of all perioperative complications | To assess the rate of occurrence of neurological and cardiopulmonary complications that may arise up to 90 days following the participant's surgical procedure. This will be assessed at 7 days, 30 days, and 90 days from the point of study entry. | 7 days, 30 days, 90 days |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with un-ruptured aneurysm(s)
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| Name | Affiliation | Role |
|---|---|---|
| Jason Chui, MBChB | Assistant Professor, Western Unviersity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Centre | London | Ontario | Canada |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Neurological outcomes |
Incidence of poor functional neurological outcomes at 7 days, 30 days and 90 days after the procedures. |
| 7 days, 30 days, 90 days |
| Length of hospital stay | Total length of stay in the neuro-critical care unit and in hospital. | From study entry until hospital discharge, or up to 90 days of after the procedure |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |