N/A
Completed N=94
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
Head and Neck Cancer · Patients Requiring a Free Flap Surgery
Source: ClinicalTrials.gov NCT02186938 ↗
Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: ICU Stay — 33.7; 58.3 hours
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ICU Stay |
33.7; 58.3 | — |
| SECONDARY Number of Participants Requiring a Ventilator |
9; 18 | — |
Eligibility Criteria
Inclusion Criteria
- adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center
Exclusion Criteria
- Patients 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.
Data sourced from ClinicalTrials.gov (NCT02186938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.