Haemodynamical Optimization During Brain Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2026-11-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Brain Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hemodynamic management based on invasive fluid responsiveness parameters

Intervention Type PROCEDURE

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)

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).

Group Type EXPERIMENTAL

Hemodynamic management based on noninvasive cardiac output and SVV measurement

Intervention Type PROCEDURE

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.

Interventions

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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)

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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