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NCT Number: NCT04114799

Haemodynamical Optimization 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).

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Key information

Conditions

Brain Edema Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemodynamic management based on invasive fluid responsiveness parameters

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)

Hemodynamic management based on noninvasive cardiac output and SVV measurement

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.

Primary outcomes

  1. 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

  1. mean dose of norepinephrine

    Time frame: 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

  2. level of creatinin

    Time frame: 24 hours

    plasma level of creatinin measured on the first postoperative day

  3. postoperative lung dysfunction

    Time frame: 1 day

    postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively

  4. length of postoperative stay

    Time frame: up to 2 month after surgery

    number of days of stay in the hospital after the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Pavel Dostal, MD, Ph.D.

CONTACT

[email protected]

+420495833218

Vlasta Dostálová, MD, Ph.D.

CONTACT

[email protected]

777883571

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Oct 3, 2019
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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