Haemodynamical Optimization During Brain Surgery

Brain Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114799
• Other study ID #: UHradec Kralove
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: University Hospital Hradec Kralove
• Contact: Vlasta Dostálová, MD, Ph.D.
• Phone: 777883571
• Email: dostavla[@]seznam.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Edema

Intervention

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)
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	level of creatinin	plasma level of creatinin measured on the first postoperative day	24 hours
Secondary	postoperative lung dysfunction	postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively	1 day
Secondary	length of postoperative stay	number of days of stay in the hospital after the surgery	up to 2 month after surgery