Perioperative Fluid Therapy Optimization in Spinal Surgery

Study Overview
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Brief Summary
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The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.

Detailed Description
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The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.

Official Title
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Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method

Conditions
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Hypovolemia, Hypervolemia

Intervention / Treatment
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* Procedure: Standard care group
* Procedure: Noninvasive monitoring group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glasgow Coma scale 15 ASA Physical Status Classification System I-III planed spinal surgery to 3 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care group<br>Fluid management will be done according standard care | Procedure: Standard care group<br>* Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).<br>|
| Experimental: Noninvasive monitoring group<br>Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards) | Procedure: Noninvasive monitoring group<br>* Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative fluid balance | the difference between fluid intake and output and losses during surgery | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean dose of norepinephrine | mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery | 5 hours | 
| level of creatinine | plasma level of creatinine measured on the first postoperative day | 24 hours | 
| pooperative lung dysfunction | postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively | 24 hours | 
| the length of postoperative stay | the length of postoperative stay in hospital | till 2 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid responsiveness, haemodynamical monitoring, ClearSight