Haemodynamical Optimization During Brain Surgery

Not Applicable

Recruiting

• Conditions: Brain Edema

• Registration Number: NCT04114799
• Lead Sponsor: University Hospital Hradec Kralove

Brief 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).

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 Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-09-07
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-04-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fluid balance difference	up to 5 hours after start of operation	the difference between fluid intake and output and losses during surgery will be calculated

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia