Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
Status: | Completed |
---|---|
Conditions: | Cardiology, Neurology, Orthopedic |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 15 - Any |
Updated: | 11/29/2017 |
Start Date: | March 2014 |
End Date: | September 2016 |
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.
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
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
Inclusion Criteria:
- Neurosurgical patients with concerns for decreased intracranial compliance;
- Orthopedic spine patients;
- Patients scheduled to undergo neurosurgical interventions that include any of the
following will be eligible: intracranial aneurysm repair; or, major spine surgery.
Exclusion Criteria:
- Patients with permanent cardiac arrhythmias;
- Patients with severe aortic regurgitation;
- Patients with intra-aortic balloon pump (IABP);
- Patients undergoing emergency surgery; and,
- Women who are pregnant and/or nursing will be excluded.
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