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

Perioperative Fluid Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728178
• Other study ID #: 2017/1122
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Fluid Management

Intervention

Other:
• Crystalloid solution
Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.
• Colloid solution
Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

Locations

Country	Name	City	State
Turkey	Istanbul University, Department of Anesthesiology	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative fluid balance	the total and additional amount of crystalloid and colloid fluid fluid given during the surgery	during surgery
Secondary	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
Secondary	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
Secondary	Heart rate	EKG	during surgery
Secondary	Blood Pressure	Arterial line and pressure transducer	during surgery
Secondary	hospitalisation time	calendar	postoperative period (up to 6 weeks)
Secondary	lenght of stay in ICU	calendar	postoperative period (up to 6 weeks)
Secondary	hypoxia	blood gas machine	during surgery
Secondary	hypercarbia	blood gas machine	during surgery
Secondary	pulmonary infection	sputum culture test	postoperative period (up to 6 weeks)