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

Effects of Goal-directed Fluid Management Guided by a Non-invasive Device on the Incidence of Postoperative Complications in Neurosurgery: a Multicenter, Prospective, Randomized, Controlled Study

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.

Patients undergoing major surgery are at risk for inadequate intravascular volumes and therefore inadequate tissue perfusion and oxygen delivery. Especially in neurosurgery, fluid management can be a challenge. In many surgical areas, such as orthopedics, gynecology or abdominal surgery, goal-directed fluid therapy is used with the aim of reducing postoperative complications. Current knowledge regarding effect of the goal-directed therapy in neurosurgery is limited.

This is a multicenter, prospective, randomized, controlled study that compares two approaches to fluid management in elective brain surgery. Patients scheduled for brain surgery will be screened whether they meet the inclusion criteria and after obtaining informed consent, the patient will be randomized to one of two study arms.

In the first (standard) arm standard vital signs monitoring will be used during the surgery and perioperative fluid management and administration of vasopressors will be guided by the decision of the attending anaesthetist.

In the second (GDT) arm perioperative fluid management and administration of vasopressors will be guided by a non-invasive hemodynamic monitor STARLINK™SV, which will be introduced in addition to standard monitoring.

The primary outcome is the incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups and their comparison. The secondary outcome is to investigate the efficacy and additional safety parameters of GDHT guided by non-invasive advanced hemodynamic monitoring versus hemodynamic management guided by standard vital signs monitoring.

This study will enroll 140 patients in total, 70 in each group. After completion of enrolment of patients the statistical analysis will be performed.

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