Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients

NYU Langone Health

Status: Completed

Conditions: Brain Edema; Surgery; Scoliosis; Intracranial Aneurysm

Treatments: Drug: Epinephrine; Other: Normal Saline; Other: Packed Red Blood Cells; Other: Voluven; Device: FloTrac Monitor; Drug: Phenylephrine; Other: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02701582

13-01043

Details and patient eligibility

About

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.

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 2 patient groups

Goal Directed Therapy

Experimental group

Description:

Flotrack monitor is connected and based on what anesthesiologist sees and following study algorithm, anesthesiologist chooses: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention.

Treatment:

Device: FloTrac Monitor

Other: Normal Saline

Drug: Epinephrine

Drug: Phenylephrine

Other: Packed Red Blood Cells

Other: Albumin

Other: Voluven

Control Group

Active Comparator group

Description:

FloTrac monitor is connected, but he anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be given a study algorithm to follow for the duration of the surgery, and based on it will choose: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention.

Treatment:

Device: FloTrac Monitor

Other: Normal Saline

Drug: Epinephrine

Drug: Phenylephrine

Other: Packed Red Blood Cells

Other: Albumin

Other: Voluven