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.
We hypothesize that the ability to assess volume status and fluid responsiveness with information gained from Edwards FloTrac/EV1000 system coupled with a goal-directed therapy fluid management algorithm can make a difference in patient outcomes. Our specific aims are: * Demonstrate goal-directed therapy (GDT) in fluid management improves peri-operative fluid balance * Demonstrate GDT improves pulmonary function and organ oxygenation * Demonstrate GDT reduces necessary therapeutic interventions in the peri- operative period * Demonstrate GDT reduces hypotensive episodes in the peri-operative period Outcomes We will study the consequences of goal-directed fluid therapy that employs use of dynamic indicators seen on FloTrac/EV1000 system by measuring the following: * Pulmonary status * Time to extubation * Alveolar-arterial (A-a) gradient of oxygen * Requirements for supplemental oxygen * Organ oxygenation * Serum lactate * Arterial blood gas values (pH, HCO3, CO2, O2) * Length of stay (LOS) * In hospital, defined as time from operation start to eligibility for discharge from hospital according to surgeon in accordance with pre-define criteria * In ICU/PACU, defined as time from operation end to eligibility for discharge from intensive care according to attending intensivist in accordance with pre- define criteria * Fluid Balance * Inputs and outputs (I/Os) of all measurable fluids (i.e. blood, crystalloid, colloid) in peri-operative period, through and including duration of intensive care or the next 24-48 hours after completion of surgery * Drugs administered for fluid management (i.e. mannitol, vasopressors) * Pre-operative and post-operative body weights and twice-daily weights via bed weights * Hypotension * Number, duration and severity (i.e. minimum blood pressure) of hypotensive episode, defined as MAP \<65
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
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.
New York University School of Medicine
New York, New York, United States
Number of ICU Stays Greater Than 1.5 Days
the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days
Time frame: 20 Days
Creatinine Change
Change in creatinine in the 72 hour post-op period (mg/dL)
Time frame: Baseline and 72 hours
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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.