Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
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.
|Head and Neck Cancer||Other: Goal directed fluid management based on continuous monitoring of stroke volume|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial|
- The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology [ Time Frame: Initiation of surgery to end of surgery on average 8-10 hours ]
- Incidence of major complication and LOS [ Time Frame: Post operative day 0 to hospital discharge ]Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded
|Study Start Date:||July 2010|
|Study Completion Date:||February 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Goal directed fluid management||
Other: Goal directed fluid management based on continuous monitoring of stroke volume
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129037
|Toronto General Hospital, UHN|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Leonid Minkovich, MD||Toronto General Hospital, UHN|