Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial

Conditions
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Perioperative Fluid Management

Intervention / Treatment
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* Other: Crystalloid solution
* Other: Colloid solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteering to participate in the study ASA classification 1, 2 or 3 The patients who will undergo head and neck surgery Exclusion Criteria: Being under the age of 18 or over the age of 80 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) The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles The patients who have a peripheral arterial disease Being a morbid obese ( BMI>40 kg/m2) the patients who may have considered difficult airway

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>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. 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. | Other: Crystalloid solution<br>* Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.<br>Other: Colloid solution<br>* Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.<br>|
| Placebo Comparator: control group<br>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. They 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. | Other: Crystalloid solution<br>* Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.<br>Other: Colloid solution<br>* Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative fluid balance | the total and additional amount of crystalloid and colloid fluid fluid given during the surgery | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged IMV demand | The need for artificial respiration for 8 hours or more in patients admitted to the postoperative intensive care unit. | during 8 hours after surgery | 
| Prolonged oxygen demand | The need for additional oxygen application with a mask for 8 hours or more in patients who are taken into postoperative service follow-up. | during 8 hours after surgery | 
| Heart rate | EKG | during surgery | 
| Blood Pressure | Arterial line and pressure transducer | during surgery | 
| hospitalisation time | calendar | postoperative period (up to 6 weeks) | 
| lenght of stay in ICU | calendar | postoperative period (up to 6 weeks) | 
| hypoxia | blood gas machine | during surgery | 
| hypercarbia | blood gas machine | during surgery | 
| pulmonary infection | sputum culture test | postoperative period (up to 6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid therapy, prolonged oxygen demand, perioperative fluid balance