Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Optimizing fluid management during brain surgery

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

Run by University Hospital Hradec Kralove · NCT04114799 · Data updated 2026-11-12

This study is testing whether using a new noninvasive monitoring system can help manage fluids better during brain surgery compared to traditional invasive methods, to see if it leads to safer outcomes for patients.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorUniversity Hospital Hradec Kralove
Academic / other
Locations1 site (Hradec Králové)
StatusRecruiting
StartedApril 1, 2019
Main results expectedApril 30, 2025
Study endsNovember 30, 2026
Registry record updatedMay 10, 2024
Trial IDNCT04114799 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with a Glasgow Coma Scale score of 15, ASA Physical Status Classification I-III, scheduled for brain tumor surgery lasting up to 5 hours.

Probably not a fit

Patients with severe heart failure (NYHA III, IV), those with a high BMI, or those requiring awake operations may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance fluid management during brain surgery by comparing two methods of hemodynamic monitoring: invasive measurements using pulse pressure variation (PPV) and systolic pressure variation (SPV) versus noninvasive measurements using the ClearSight system. The goal is to reduce perioperative risks and improve patient outcomes by ensuring adequate fluid management based on the most effective monitoring technique. Participants will be assigned to either the invasive or noninvasive group to evaluate the effectiveness of each approach in optimizing fluid responsiveness.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing brain surgery.

How similar studies have gone: Other studies have shown promise in optimizing fluid management using similar hemodynamic monitoring techniques, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University Hospital Hradec Kralove
    Hradec Králové, Czechia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.