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
Completed · Not applicable
Conditions studied: Head and Neck Cancer, Patients Requiring a Free Flap Surgery
In brief
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.
Key facts
- Study ID
- NCT02186938
- Run by
- Medical University of South Carolina
- People needed
- 94
- Starts
- 2012-12-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2018-09-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center
You may not qualify if…
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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