Head and Neck Cancer Clinical Trial
Official title:
Does the Intraoperative Use of the FloTrac Device to Guide Fluid and Vasopressor Management Affect Postoperative Morbidity in Patients Receiving a Head and Neck Microvascular Free Tissue Transfer
This study aims to investigate whether the intraoperative use of the FloTrac device to guide fluid and vasopressor management during head and neck free flap surgery improves postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary postoperative outcomes include days in ICU, days on ventilator, presence of postoperative pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap complication rate, inpatient postoperative cardiorespiratory complications/events, and overall 30 day flap failure rate.
Few animal models have shown that intravenous vasopressor administration (including use of
pure alpha agonists such as phenylephrine) can decrease blood flow to free musculocutaneous
flaps (1-3). This has led to a dogmatic belief that all vasopressors should be avoided
intraoperatively during a microvascular free flap reconstruction regardless of patient
hemodynamics, even though there is little published evidence that pressors negatively affect
free flap outcome (4). As a result, these patients often receive generous amounts of fluids
during their intraoperative course to combat periods of hypotension. However, patients
receiving head and neck free tissue transfers tend to be older with serious comorbidities
related to long term tobacco use such as significant cardiovascular and pulmonary disease.
Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that
may not necessarily be related to hypovolemia. Consistently treating periods of hypotension
with more intravenous fluids can lead to serious postoperative complications such as graft
failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a
retrospective review of 248 patients over a 34 month period that received a head and neck
free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid
administration significantly increased 30 day flap complication rate while intraoperative
administration of vasopressors did not affect 30 day flap complication or 30 day failure
rate.
The FloTrac device is an approved and validated medical device that analyzes the arterial
pressure waveform to calculate a stroke volume variation. This stroke volume variation can be
used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor
management during periods of intraoperative hypotension (5). The use of the FloTrac device
for goal directed therapy has been investigated in major abdominal surgery and found to
decrease length of hospital stay and complication rate in this surgical population (5-6).
Thus, it is possible that the intraoperative use of the FloTrac device can better guide
anesthesia providers to provide the necessary therapy for intraoperative hypotension in
patients undergoing head and neck freet tissue transfer, thus improving postoperative
outcome.
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