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Clinical Trials/NCT04114799
NCT04114799
Recruiting
Not Applicable

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

University Hospital Hradec Kralove1 site in 1 country50 target enrollmentApril 1, 2019
ConditionsBrain Edema

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Edema
Sponsor
University Hospital Hradec Kralove
Enrollment
50
Locations
1
Primary Endpoint
fluid balance difference
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
November 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dostalova Vlasta, MD, PhD

principal investigator

University Hospital Hradec Kralove

Eligibility Criteria

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

Outcomes

Primary Outcomes

fluid balance difference

Time Frame: up to 5 hours after start of operation

the difference between fluid intake and output and losses during surgery will be calculated

Secondary Outcomes

  • mean dose of norepinephrine(up to 5 hours after start of operation)
  • length of postoperative stay(up to 2 month after surgery)
  • level of creatinin(24 hours)
  • postoperative lung dysfunction(1 day)

Study Sites (1)

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