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
NCT number | NCT02186938 |
Other study ID # | ENT FloTrac |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2012 |
Est. completion date | October 2014 |
Verified date | August 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICU Stay | The primary outcome is length of ICU stay. | Participants were assessed from entry into ICU until departure. | |
Secondary | Number of Participants Requiring a Ventilator | The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator | The number of participants requiring a ventilator after surgery. |
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