Haemodynamical Optimization During Brain Surgery
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A invasive haemodynamical measurement 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
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)
|
| Experimental: Group B non-invasive haemodynamical measurement 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
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.
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Outcome Measures
Primary Outcome Measures
- fluid balance difference [up to 5 hours after start of operation]
the difference between fluid intake and output and losses during surgery will be calculated
Secondary Outcome Measures
- mean dose of norepinephrine [up to 5 hours after start of operation]
mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery
- level of creatinin [24 hours]
plasma level of creatinin measured on the first postoperative day
- postoperative lung dysfunction [1 day]
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively
- length of postoperative stay [up to 2 month after surgery]
number of days of stay in the hospital after the surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Glasgow Coma scale 15
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ASA Physical Status Classification System I-III
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planed surgery for brain tumor to 5 hours
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postoperative awakening
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sinus rhythm
Exclusion Criteria:
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NYHA III, IV
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BMI over 40 in females and over 35 in men
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awake operation
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postoperative artificial ventilation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Hradec Kralove | Hradec Kralove | Czechia | 50005 |
Sponsors and Collaborators
- University Hospital Hradec Kralove
Investigators
- Study Director: Pavel Dostal, MD, Ph.D., University Hospital Hradec Kralove
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UHradec Kralove