Brain Edema
Conditions
Keywords
fluid responsiveness, haemodynamical monitoring, ClearSight
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.
Interventions
PROCEDUREHemodynamic 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)
PROCEDUREHemodynamic 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.
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Czechia
Contacts
Primary ContactVlasta Dostálová, MD, Ph.D.
Backup ContactPavel Dostal, MD, Ph.D.
Outcome results
None listed