Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

Study Overview
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Brief Summary
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Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients. Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.

Official Title
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Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Goal directed fluid management based on continuous monitoring of stroke volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Signed informed consent Exclusion Criteria: History CHF Severe valvular heart defects, intra cardiac shunts Irregular heart rhythm Allergy to hydroxyethyl starch solutions Coagulation abnormalities (INR>1.5, aPTT>40s, platelet count<100x10 9/L History of severe bleeding disorders Renal insufficiency with creatinine >200Umol/L Pregnant of nursing women History of skin disorders that are accompanied by chronic puritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Goal directed fluid management<br> | Other: Goal directed fluid management based on continuous monitoring of stroke volume<br>* Baseline SV measurement, repeated volume loading (VL) with aliquots of 250 ml HES until SV increased < 10% in response to receding VL: SV is optimized, no further VL required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology |  | Initiation of surgery to end of surgery on average 8-10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major complication and LOS | Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded | Post operative day 0 to hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology