Haemodynamical Optimization During Brain Surgery

University Hospital Hradec Kralove

Status: Enrolling

Conditions: Brain Edema

Treatments: Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement; Procedure: Hemodynamic management based on invasive fluid responsiveness parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT04114799

UHradec Kralove

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group A invasive haemodynamical measurement

Active Comparator group

Description:

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.

Treatment:

Procedure: Hemodynamic management based on invasive fluid responsiveness parameters

Group B non-invasive haemodynamical measurement

Experimental group

Description:

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).

Treatment:

Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement