Haemodynamical Optimization During Brain Surgery

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

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).

Study Overview

• Status: Recruiting
• Conditions: Brain Edema
• Intervention / Treatment: Procedure: Hemodynamic management based on invasive fluid responsiveness parameters; Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vlasta Dostálová, MD, Ph.D.; Phone Number: 777883571; Email: dostavla@seznam.cz
• Study Contact Backup: Name: Pavel Dostal, MD, Ph.D.; Phone Number: +420495833218; Email: pavel.dostal@fnhk.cz

Study Locations

• Czechia
  • Hradec Kralove, Czechia, 50005
    • Recruiting
    • University Hospital Hradec Kralove
    • Contact: Pavel Dostal, MD, PhD; Phone Number: 00420495833218; Email: pavel.dostal@fnhk.cz
    • Contact: Pavel Dostal, MD, PhD; Phone Number: 00420495832266; Email: pavel.dostal@fnhk.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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)
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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fluid balance difference	the difference between fluid intake and output and losses during surgery will be calculated	up to 5 hours after start of operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean dose of norepinephrine	mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery	up to 5 hours after start of operation
level of creatinin	plasma level of creatinin measured on the first postoperative day	24 hours
postoperative lung dysfunction	postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively	1 day
length of postoperative stay	number of days of stay in the hospital after the surgery	up to 2 month after surgery

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: September 7, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: fluid responsiveness; haemodynamical monitoring; ClearSight
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Edema
• Other Study ID Numbers: UHradec Kralove

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No