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
Status: Recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Glasgow Coma scale 15
• ASA Physical Status Classification System I-III
• planed surgery for brain tumor to 5 hours
• postoperative awakening
• sinus rhythm
Contact Information
Primary
Vlasta Dostálová, MD, Ph.D.
dostavla@seznam.cz
777883571
Backup
Pavel Dostal, MD, Ph.D.
pavel.dostal@fnhk.cz
+420495833218
Time Frame
Start Date: 2019-04-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 50
Treatments
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.
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).
Related Therapeutic Areas
Sponsors
Leads: University Hospital Hradec Kralove