Haemodynamical Optimization During Brain Surgery
- Conditions
- Brain Edema
- Interventions
- Procedure: Hemodynamic management based on invasive fluid responsiveness parametersProcedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement
- Registration Number
- NCT04114799
- Lead Sponsor
- University Hospital Hradec Kralove
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Glasgow Coma scale 15
- ASA Physical Status Classification System I-III
- planed surgery for brain tumor to 5 hours
- postoperative awakening
- sinus rhythm
- NYHA III, IV
- BMI over 40 in females and over 35 in men
- awake operation
- postoperative artificial ventilation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A invasive haemodynamical measurement Hemodynamic management based on invasive fluid responsiveness parameters 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. Group B non-invasive haemodynamical measurement Hemodynamic management based on noninvasive cardiac output and SVV 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
length of postoperative stay up to 2 month after surgery number of days of stay in the hospital after 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
Trial Locations
- Locations (1)
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia