Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093, Turkey (Türkiye)
NCT Number: NCT04728178
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Istanbul, Fatih, 34093, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.
Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.
Time frame: during surgery
the total and additional amount of crystalloid and colloid fluid fluid given during the surgery
Time frame: during 8 hours after surgery
The need for artificial respiration for 8 hours or more in patients admitted to the postoperative intensive care unit.
Time frame: during 8 hours after surgery
The need for additional oxygen application with a mask for 8 hours or more in patients who are taken into postoperative service follow-up.
Time frame: during surgery
EKG
Time frame: during surgery
Arterial line and pressure transducer
Time frame: postoperative period (up to 6 weeks)
calendar
Time frame: postoperative period (up to 6 weeks)
calendar
Time frame: during surgery
blood gas machine
Time frame: during surgery
blood gas machine
Time frame: postoperative period (up to 6 weeks)
sputum culture test
Istanbul University
Other
Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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