At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
In Brief
A clinical study evaluating Phenylephrine, Epinephrine, and 5 other interventions for Intracranial Aneurysm and 3 related conditions. Completed, enrolled 66 participants across 1 site.
Detailed Summary
This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex spinal surgery including multi-level scoliosis correction, is a more effective way of monitoring fluid.
Study Details
Timeline
Interventions
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \< 13 and Cardiac Index is \>=2.2 Phenylephrine is administered
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \< 13 and Cardiac Index is \< 2.2 Epinephrine is administered
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \> = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is \> 65, Stroke volume variation (SVV) \> = 13 and Cardiac Index is \<2.2 fluids are administered.
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \> = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is \> 65, Stroke volume variation (SVV) \> = 13 and Cardiac Index is \<2.2 fluids are administered.
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \> = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is \> 65, Stroke volume variation (SVV) \> = 13 and Cardiac Index is \<2.2 fluids are administered.
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \> = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is \> 65, Stroke volume variation (SVV) \> = 13 and Cardiac Index is \<2.2 fluids are administered.
FloTrac monitor is connected for all patients, but only visible to the anesthesiologist for half. Based on a decision tree and the data from monitor, choices of interventions are used.