Status:
COMPLETED
A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps
Lead Sponsor:
Medical University of South Carolina
Conditions:
Head and Neck Cancer
Patients Requiring a Free Flap Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Pri...
Detailed Description
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...
Eligibility Criteria
Inclusion
- adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center
Exclusion
- Patients \< 55kg or \> 140 kg based on literature regarding accuracy of flotrac.
- Patients with sustained intraoperative dysrrhythmias based on literature regarding accuracy of flotrac (ie, atrial flutter, atrial fibrillation).
- Patients with diagnosed NYHA class III-IV failure or documented EF \< 30%
- Patients with pulmonary disease preventing administration of goal tidal volumes without excessive inspiratory pressures.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT02186938
Start Date
December 1 2012
End Date
October 1 2014
Last Update
September 20 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425