Goal-directed Therapy in Neurosurgery.

Study Overview
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Brief Summary
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The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.

Detailed Description
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Patients undergoing neurosurgical operations are at risk of inadequate intravascular volume for several reasons. The appropriate fluid management in neurosurgery is a challenge. Goal-directed therapy has been shown to improve the outcome of patients undergoing major surgery. Current knowledge regarding effect of fluid management on patient-orientated outcomes in neurosurgery is limited. This study is designed as a pilot study with two parallel groups. Patients scheduled to planned brain surgery at the University Hospital Brno will be screened whether they meet the inclusion criteria. After obtaining informed consent, the patient will be randomized to one of the study arms. In one arm (STANDARD) standard monitoring of vital signs will be introduced. During the operation, perioperative fluid therapy and administration of vasoactive agents will depend entirely at the discretion of the attending anaesthetist. Postoperative therapy will be fully controlled and will depend on the decision of the attending physician. In the second arm (GDT), a non-invasive hemodynamic monitor STARLINK™SV will be introduced in addition to standard monitoring. In this arm, basal infusion with crystalloid balanced solution will be initiated. Additional boluses of fluids will be administered based on haemodynamic monitoring. The primary outcome of the study is a proportion of patients with serious adverse event (SAE). Incidence of SAEs will be compared between study groups. SAE will be defined as unsatisfactory brain tissue relaxation at the end of operation and any intervention for brain oedema postoperatively. The secondary outcome is to compare proportion of patients with postoperative complications in both groups and length of ICU and hospital stay. This study will enroll 34 patients in total, 17 in each group. After completion of enrolment of patients the statistical analysis will be performed.

Official Title
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Effect of Goal-directed Fluid Management Guided by Non-invasive Device on Incidence of Postoperative Complications in Neurosurgery: Pilot Study

Conditions
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Surgery--Complications

Intervention / Treatment
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* Other: Goal-Directed Therapy
* Other: STANDARD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age at least 18 years anticipated duration of surgery at least 2 hours signed written consent form American Society of Anesthesiologists (ASA) classification < 4. Exclusion Criteria: unavailability of hemodynamic monitor emergency operation ASA ≥4 sitting operating position and awake craniotomy awake craniotomy serious cardiorespiratory disorder cardiac arrythmia obesity with BMI above 35 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STANDARD<br>In this arm standard monitoring of vital signs will be used during operation. | Other: STANDARD<br>* Administration of fluids and vasoactive drugs guided by standard vital signs monitoring<br>|
| Experimental: GDT<br>A non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring. | Other: Goal-Directed Therapy<br>* Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events 1 | Assessment of number of patients with serious adverse event (SAE). SAE is defined as unsatisfactory brain tissue relaxation at the end of surgery assessed by neurosurgeon. Level 3 or 4 of brain tissue relaxation will be considered as unsatisfactory (level 1 - completely relaxed, level 2 - satisfactorily relaxed, level 3 - firm, level 4 - bulging). | During the Surgery | 
| Serious Adverse Events 2 | Assessment of number of patients with serious adverse event (SAE). SAE is defined as any intervention indicated for treatment of brain edema 24 hours after surgery. | 24 hours postoperatively | 
| Recruitment rate | Proportion of eligible patients who consent to participate in the study. | through study completion, an average of 6 months | 
| Completeness of Case Report Forms | Proportion of enrolled patients with completed Case Report Form. | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Number of patients with pre-defined postoperative complication. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurosurgery, Goal-Directed Therapy, Complications, Pilot study