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NCT07101991
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
Conditions: Surgery Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Brno University Hospital
Location: The University Hospital Brno Brno
Summary
This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring.
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
Source: ClinicalTrials.gov (NCT07101991). StuddyBuddy aggregates publicly available trial information.