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

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

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Fluid Management
• Intervention / Treatment: Other: Crystalloid solution; Other: Colloid solution

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Istanbul University, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: study group; 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; Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.; Other: Colloid solution; Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.
PLACEBO_COMPARATOR: control group; 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; Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.; Other: Colloid solution; Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Demet Altun Bingol, Assoc. Prof., Istanbul University; Principal Investigator: Nuray Turkut, MD, Istanbul University; Principal Investigator: Cansu Uzuntürk, Resident, Istanbul University; Principal Investigator: Emre Çamcı, Prof., Istanbul University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: fluid therapy; prolonged oxygen demand; perioperative fluid balance
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 2017/1122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No