Haemodynamical Optimization During Brain Surgery

Study Overview
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Brief Summary
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The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).

Detailed Description
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The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes. This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.

Official Title
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A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery

Conditions
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Brain Edema

Intervention / Treatment
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* Procedure: Hemodynamic management based on invasive fluid responsiveness parameters
* Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glasgow Coma scale 15 ASA Physical Status Classification System I-III planed surgery for brain tumor to 5 hours postoperative awakening sinus rhythm Exclusion Criteria: NYHA III, IV BMI over 40 in females and over 35 in men awake operation postoperative artificial ventilation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A invasive haemodynamical measurement<br>No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness. | Procedure: Hemodynamic management based on invasive fluid responsiveness parameters<br>* In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)<br>|
| Experimental: Group B non-invasive haemodynamical measurement<br>No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards). | Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement<br>* In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid balance difference | the difference between fluid intake and output and losses during surgery will be calculated | up to 5 hours after start of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean dose of norepinephrine | mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery | up to 5 hours after start of operation | 
| level of creatinin | plasma level of creatinin measured on the first postoperative day | 24 hours | 
| postoperative lung dysfunction | postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively | 1 day | 
| length of postoperative stay | number of days of stay in the hospital after the surgery | up to 2 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid responsiveness, haemodynamical monitoring, ClearSight