Optimizing fluid management during brain surgery
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
NA · University Hospital Hradec Kralove · NCT04114799
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Hradec Kralove (other) |
| Locations | 1 site (Hradec Králové) |
| Trial ID | NCT04114799 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in optimizing fluid management using similar hemodynamic monitoring techniques, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Hradec Králové
- University Hospital Hradec Kralove — Hradec Králové, Czechia (RECRUITING)
Study contacts
- Study coordinator: Vlasta Dostálová, MD, Ph.D.
- Email: dostavla@seznam.cz
- Phone: 777883571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Edema, fluid responsiveness, haemodynamical monitoring, ClearSight