Clinical trial NCT04728178: Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management
Official title: Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Fluid Management
Keywords: fluid therapy
prolonged oxygen demand
perioperative fluid balance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the goal-directed fluid therapy based on the data obtained from the hemodynamic monitoring system, which provides continuous CO, SV and SVV measurements through arterial pressure wave with standard fluid therapy in perioperative fluid management of patients undergoing head and neck surgery.

Detailed description: Following the ethics committee approval and patients consent, the study was completed with a total of ASA I-III, 60 patients over the age of 18 who will undergo head and neck surgery.After randomization, patients underwent arterial cannulation. The arterial cannulas of the study group patients were integrated into the hemodynamic monitoring system with a special transducer, and their fluid management was planned to achieve a target value of 13% or less through SVV monitoring. In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started in both groups. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg. The patients in the control group were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.

Eligibility criteria: Inclusion Criteria:

1. Volunteering to participate in the study
2. ASA classification 1, 2 or 3
3. The patients who will undergo head and neck surgery

Exclusion Criteria:

1. Being under the age of 18 or over the age of 80
2. Presence of serious cardiac, renal and liver pathology ( ejection fraction\< %35 and/or glomerular filtration rate\< 30ml/kg/min, kreatinin\>2,5mg/dl and/or abnormal liver function test)
3. The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles
4. The patients who have a peripheral arterial disease
5. Being a morbid obese ( BMI\>40 kg/m2)
6. the patients who may have considered difficult airway

Primary outcomes:
measure: Intraoperative fluid balance
timeFrame: during surgery
Secondary outcomes:
measure: Prolonged IMV demand
timeFrame: during 8 hours after surgery
measure: Prolonged oxygen demand
timeFrame: during 8 hours after surgery
measure: Heart rate
timeFrame: during surgery
measure: Blood Pressure
timeFrame: during surgery
measure: hospitalisation time
timeFrame: postoperative period (up to 6 weeks)
measure: lenght of stay in ICU
timeFrame: postoperative period (up to 6 weeks)
measure: hypoxia
timeFrame: during surgery
measure: hypercarbia
timeFrame: during surgery
measure: pulmonary infection
timeFrame: postoperative period (up to 6 weeks)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
state: Fatih
Study officials:
affiliation: Istanbul University
name: Demet Altun Bingol, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Nuray Turkut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Cansu Uzuntürk, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Emre Çamcı, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davies SJ, Minhas S, Wilson RJ, Yates D, Howell SJ. Comparison of stroke volume and fluid responsiveness measurements in commonly used technologies for goal-directed therapy. J Clin Anesth. 2013 Sep;25(6):466-74. doi: 10.1016/j.jclinane.2013.04.010. Epub 2013 Aug 17.
citation: Funk D, Bohn J, Mutch W, Hayakawa T, Buchel EW. Goal-directed fluid therapy for microvascular free flap reconstruction following mastectomy: A pilot study. Plast Surg (Oakv). 2015 Winter;23(4):231-4. doi: 10.4172/plastic-surgery.1000937.