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Clinical Trials/NCT06776666
NCT06776666CompletedNot Applicable

Comparison of Pulse Pressure Variation and Central Venous Pressure for Fluid Management Guidance in Intracranial Tumor Surgery

Pamukkale University1 site in 1 country42 target enrollmentStarted: April 3, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Fluid requirement (number of times needing bolus infusion-during surgery)

Study Overview

Brief Summary

This study investigates the efficacy of pulse pressure variation (PPV) compared to central venous pressure (CVP) in guiding fluid management during intracranial tumor surgeries. Perioperative fluid therapy is critical to prevent complications arising from both hypovolemia (e.g., hypotension, tissue hypoperfusion, ischemia) and hypervolemia (e.g., pulmonary edema, delayed wound healing, infection). Traditional fluid therapy relies on static parameters such as CVP, which have limited sensitivity and specificity. Emerging technologies and dynamic parameters, including PPV and stroke volume variation (SVV), offer higher accuracy in evaluating fluid responsiveness.

This randomized study includes 42 patients, aged 18-65 years, undergoing elective intracranial tumor surgery under general anesthesia. Patients are classified as ASA I-III and are randomized into two groups:

  1. Group N: Fluid therapy guided by PPV.
  2. Group S: Fluid therapy guided by CVP. The study follows standard perioperative protocols, with PPV (>13%) and CVP (0-6 mmHg) used as primary parameters for fluid administration. Key outcomes include intraoperative fluid requirements (primary) and secondary parameters such as serum lactate levels, incidence of hypotension, brain relaxation scores, and ICU length of stay.

PPV has been shown to be more reliable than CVP in predicting fluid responsiveness, particularly in mechanically ventilated patients with tidal volumes ≥8 mL/kg. However, its efficacy in neurosurgical patients remains underexplored. This study aims to determine if PPV can replace CVP as a superior guide for fluid therapy, enhancing patient outcomes and minimizing complications.

Detailed Description

To prevent fluid losses secondary to surgery, fluid therapy should be administered to patients during the preoperative, intraoperative, and postoperative periods. The goal of perioperative fluid therapy is to maintain adequate circulating volume and pressure, avoid dehydration and the adverse effects of excessive fluid administration, and optimize oxygen delivery to tissues to ensure sufficient perfusion. Inadequate fluid administration can result in hypovolemia, leading to complications such as hypotension, tissue hypoperfusion, ischemia, arrhythmias, and renal damage. Conversely, excessive fluid administration can cause hypervolemia-related issues, including fluid accumulation in tissues (especially in the lungs), impaired tissue perfusion, prolonged mechanical ventilation, anastomotic leaks, delayed wound healing, and infections. Postoperative complications can also increase morbidity, mortality, and healthcare costs. Therefore, achieving normovolemia in patients during the perioperative period is of paramount importance.

In traditional fluid therapy, hourly fluid requirements for maintenance and fasting-related deficits are calculated using the '4-2-1' rule (4 mL/kg/hour for the first 10 kg, 2 mL/kg/hour for the next 10 kg, and 1 mL/kg/hour for each kilogram thereafter). Estimated fluid losses from surgical bleeding and evaporation are added to these calculations for replacement. In traditional fluid therapy, intravascular volume is estimated using parameters such as arterial blood pressure, heart rate (HR), and urine output. However, these parameters are influenced by many factors and do not always accurately reflect intravascular volume. Managing patients using these parameters, especially in high-risk surgeries, can result in complications related to hypovolemia and hypervolemia. The lack of an optimal perioperative fluid therapy approach in high-risk surgeries has led to new explorations, including personalized, goal-directed fluid therapy facilitated by advanced technological devices. Studies have shown that personalized, goal-directed fluid therapy improves postoperative outcomes.

Various static parameters have been used to guide fluid therapy to date, one of which is CVP (central venous pressure), commonly employed in clinical practice. The normal range of CVP in the supine position is 0-6 mmHg. A CVP below this range indicates hypovolemia, while a CVP above it suggests hypervolemia. Recent studies have shown that CVP's sensitivity and specificity in detecting fluid deficits are insufficient.

In recent years, dynamic parameters with high sensitivity and specificity, such as PPV (pulse pressure variation) and SVV (stroke volume variation), have been increasingly utilized to assess fluid deficits. Changes in arterial pressure waveforms during respiration are used to evaluate the response to fluid administration. These changes occur during controlled mechanical ventilation. Positive pressure ventilation increases intrathoracic pressure during inspiration, reducing venous return, right ventricular filling volume, and left ventricular stroke volume. During expiration, the effects are reversed. If arterial vasomotor tone and cardiac function remain constant, these changes in stroke volume during positive pressure ventilation are reflected in pulse pressure and systolic blood pressure. In fluid-nonresponsive patients, variations in these dynamic parameters are less than 10%.

In mechanically ventilated, hemodynamically stable, and intubated patients with a tidal volume ≥8 mL/kg, a stroke volume variation (SVV) >10% and a pulse pressure variation (PPV) >13% indicate a fluid deficit.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ages of 18-65
  • ASA (American Society of Anesthesiology) physical status classification score I-III
  • who will undergo elective intracranial mass surgery under general anesthesia

Exclusion Criteria

  • Patients with renal failure
  • mental retardation
  • arrhythmia
  • severe cardiopulmonary disease
  • hemodynamic instability
  • body mass index (BMI) >40 kg/m2
  • respiratory system compliance (Crs) <30 mL/cmH2O
  • use of lactate-producing drugs such as metformin
  • lactate elevation at the beginning of the operation
  • tumor causing diabetes insipitus
  • patients who do not accept the procedure

Outcomes

Primary Outcomes

Fluid requirement (number of times needing bolus infusion-during surgery)

Time Frame: At 10-minutes intervals throughout the surgery

Fluid requirement (number of times needing bolus infusion) One bolus infusion 250 mL amount Bolus fluid requirement will be assessed every 15 minutes throughout the operation. Assesment will make two method: CVP and PPV. Will be to compare the intraoperative fluid requirement between the two groups. 1. CVP (Central Venous Pressure) group: In cases where CVP\<6 mmHg during the intraoperative period, patients will be given an additional 250 ml bolus crystalloid infusion over a 10 minute period and LVB will be re-evaluated. 2. PPV (Pulse Pressure Variation) group: In cases where the pulse pressure variations value is \>13%, patients will be given an additional 250 ml of crystalloid fluid over a 10 minute period and pulse pressure variations will be reassessed.

Secondary Outcomes

  • Duration of postoperative stay in the intensive care unit(in 2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gizem Demirci

Principal investigator

Pamukkale University

Study Sites (1)

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