CompletedNot Applicable

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

United States94 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center Exclusion Criteria: * 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.

What they're measuring

ICU Stay

Timeframe: Participants were assessed from entry into ICU until departure.

Trial details

NCT IDNCT02186938

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

Results submitted2016-03-16

View on ClinicalTrials.gov More Head and Neck Cancer trials