Head and Neck Cancer, Patients Requiring a Free Flap Surgery
Conditions
Keywords
head and neck cancer, patients requiring a free flap surgery
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. 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.
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 has led to a dogmatic belief that all vasopressors should be avoided intraoperatively during a microvascular free flap reconstruction regardless of patient hemodynamics, even though there is little published evidence that pressors negatively affect free flap outcome (4). As a result, these patients often receive generous amounts of fluids during their intraoperative course to combat periods of hypotension. However, patients receiving head and neck free tissue transfers tend to be older with serious comorbidities related to long term tobacco use such as significant cardiovascular and pulmonary disease. Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that may not necessarily be related to hypovolemia. Consistently treating periods of hypotension with more intravenous fluids can lead to serious postoperative complications such as graft failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a retrospective review of 248 patients over a 34 month period that received a head and neck free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid administration significantly increased 30 day flap complication rate while intraoperative administration of vasopressors did not affect 30 day flap complication or 30 day failure rate. The FloTrac device is an approved and validated medical device that analyzes the arterial pressure waveform to calculate a stroke volume variation. This stroke volume variation can be used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor management during periods of intraoperative hypotension (5). The use of the FloTrac device for goal directed therapy has been investigated in major abdominal surgery and found to decrease length of hospital stay and complication rate in this surgical population (5-6). Thus, it is possible that the intraoperative use of the FloTrac device can better guide anesthesia providers to provide the necessary therapy for intraoperative hypotension in patients undergoing head and neck freet tissue transfer, thus improving postoperative outcome.
Interventions
DEVICEFloTrac
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Stay | Participants were assessed from entry into ICU until departure. | The primary outcome is length of ICU stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring a Ventilator | The number of participants requiring a ventilator after surgery. | The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group FloTrac device was used to manage blood pressure during surgery. | 47 |
| Control Group FlotTrac device was not used. Blood pressure of the control group was managed with standard methods. | 47 |
| Total | 94 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 59.1 years | 57.6 years | 57.7 years |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 35 Participants | 35 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
ICU Stay
The primary outcome is length of ICU stay.
Time frame: Participants were assessed from entry into ICU until departure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | ICU Stay | 33.7 hours |
| Control Group | ICU Stay | 58.3 hours |
Secondary
Number of Participants Requiring a Ventilator
The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator
Time frame: The number of participants requiring a ventilator after surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Number of Participants Requiring a Ventilator | 9 participants |
| Control Group | Number of Participants Requiring a Ventilator | 18 participants |