Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery

Launched by BRNO UNIVERSITY HOSPITAL · Jul 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor and manage blood flow and heart function during planned brain surgeries to help reduce complications. It will compare two groups of patients: one group will receive this specialized monitoring using a device called the Starling™ SV System, which is non-invasive (meaning it doesn’t require needles or surgery), while the other group will be monitored using standard methods like regular vital signs (heart rate, blood pressure, etc.). The goal is to see if this new approach is safe and helps improve patient outcomes during surgery.

Adults aged 18 and older who are scheduled for certain types of elective (planned) brain surgery lasting at least two hours may be eligible to participate. Patients need to be in relatively good health based on a standard classification system used by doctors (ASA category 1 to 3) and must be positioned lying on their back or side during surgery. People with severe health issues, emergency brain injuries, or who are pregnant or breastfeeding will not be eligible. If you take part, you will be closely monitored during your surgery using one of the two methods, and your medical team will use this information to guide your care. The study is not yet recruiting, but it aims to find better ways to support patients during brain surgery and improve recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects will be eligible for the trial if they meet all of the following criteria:
• • Age ≥ 18 years
• • Elective brain surgery with an expected duration ≥ 2 h
• • Category 1-3 according to the ASA (American Society of Anesthesiologists) Physical Status Classification
• • Lateral or supine operative position
• • Signed the relevant informed consent form
• Exclusion Criteria:
• Subjects will not be eligible for the trial if they meet any of the following criteria:
• • Category 4 according to the ASA Physical Status Classification
• • Surgery for traumatic brain injury or acute hemorrhagic stroke
• • Awake brain surgery
• • Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)
• • Unavailability of hemodynamic monitoring data
• • Cardiac arrhythmia with irregular cardiac rhythm
• • Known hypersensitivity to the active substance or to any of the excipients of IMP (Investigational Medicinal Product)
• • Pregnancy and lactation