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Completed

NCT Number: NCT04728178

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crystalloid solution

Other

Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.

Colloid solution

Other

Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

Primary outcomes

  1. Intraoperative fluid balance

    Time frame: during surgery

    the total and additional amount of crystalloid and colloid fluid fluid given during the surgery

Secondary outcomes

  1. Prolonged IMV demand

    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.

  2. Prolonged oxygen demand

    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.

  3. Heart rate

    Time frame: during surgery

    EKG

  4. Blood Pressure

    Time frame: during surgery

    Arterial line and pressure transducer

  5. hospitalisation time

    Time frame: postoperative period (up to 6 weeks)

    calendar

  6. lenght of stay in ICU

    Time frame: postoperative period (up to 6 weeks)

    calendar

  7. hypoxia

    Time frame: during surgery

    blood gas machine

  8. hypercarbia

    Time frame: during surgery

    blood gas machine

  9. pulmonary infection

    Time frame: postoperative period (up to 6 weeks)

    sputum culture test

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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