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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Locations | 1 site (Hradec Králové) |
| Status | Recruiting |
| Started | April 1, 2019 |
| Main results expected | April 30, 2025 |
| Study ends | November 30, 2026 |
| Registry record updated | May 10, 2024 |
| Trial ID | NCT04114799 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
- Study coordinator: Vlasta Dostálová, MD, Ph.D.
- Email: dostavla@seznam.cz
- Phone: 777883571
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.