Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery

Study Overview
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Brief Summary
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In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

Detailed Description
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In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. As a preload index, the predictability of central venous pressure, pulse pressure variation and stroke volume variations may be impaired due to the impaired hemodynamics that result from the effect of increased abdominal pressure and decreased venous return. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

Official Title
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Comparison of Positive End-expiratory Pressure-induced Increase in Central Venous Pressure and Stroke Volume Variation to Predict Fluid Responsiveness in Robot-assisted Laparoscopic Surgery: A Prospective Clinical Trial

Conditions
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Prostatic Neoplasm, Urinary Bladder Neoplasm

Intervention / Treatment
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* Procedure: Fluid loading of volulyte 300 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy. American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3. Exclusion Criteria: Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction. Valvular or ischemic heart disease or left ventricular ejection fraction less than 40%. Any significant pulmonary disease or history of chronic obstructive pulmonary disease End-stage renal disease or preoperative creatinine > 1.4 mg/dl

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluid responsiveness test<br>First, apply 10 cmH2O positive endexpiratory pressure (PEEP) and measure the increase in central venous pressure (CVP) as well as other preload indexes (central venous pressure, mean arterial pressure, stroke volume variation). Second, measure the increase in cardiac index after administration of volulyte 300 ml. If cardiac index increase more than 10%, fluid responsiveness is confirmed. | Procedure: Fluid loading of volulyte 300 ml<br>* Administration of volulyte 300 ml and measurement of increase in cardiac index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid responsiveness | fluid responsiveness is determined when increase in cardiac index is more than 10% | 5 minutes after administration of 300 ml volulyte | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central venous pressure | T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero | one hour after the initiation of pneumoperitoneum | 
| cardiac index | T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero | one hour after the initiation of pneumoperitoneum | 
| stroke volume variation | T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero | one hour after the initiation of pneumoperitoneum | 
| abdominal pressure | T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero | one hour after the initiation of pneumoperitoneum | 
| central venous pressure | T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure | 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O | 
| cardiac index | T2: measurement of cardiac index | 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O | 
| stroke volume variation | T2: measurement of stroke volume variation | 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O | 
| abdominal pressure | T2: measurement of abdominal pressure | 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O | 
| central venous pressure | T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero | 5 minutes after removal of positive end-expiratory pressure | 
| cardiac index | T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero | 5 minutes after removal of positive end-expiratory pressure | 
| stroke volume variation | T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero | 5 minutes after removal of positive end-expiratory pressure | 
| abdominal pressure | T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero | 5 minutes after removal of positive end-expiratory pressure | 
| central venous pressure | measurement of central venous pressure after fluid administration | T4: 5 minutes after administration of volulyte 300 ml | 
| cardiac index | measurement of cardiac index after fluid administration | T4: 5 minutes after administration of volulyte 300 ml | 
| stroke volume variation | measurement of stroke volume variation after fluid administration | T4: 5 minutes after administration of volulyte 300 ml | 
| abdominal pressure | measurement of abdominal pressure after fluid administration | T4: 5 minutes after administration of volulyte 300 ml | 
| arterial oxygen partial pressure (mmHg) | arterial blood gas analysis | 5 minutes after anesthesia induction | 
| arterial carbon dioxide partial pressure (mmHg) | arterial blood gas analysis | 5 minutes after anesthesia induction | 
| arterial oxygen partial pressure (mmHg) | arterial blood gas analysis | 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O | 
| arterial carbon dioxide partial pressure (mmHg) | arterial blood gas analysis | 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O | 
| arterial oxygen partial pressure (mmHg) | arterial blood gas analysis | 1 minutes after the start of skin closure | 
| arterial carbon dioxide partial pressure (mmHg) | arterial blood gas analysis | 1 minutes after the start of skin closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid responsiveness, central venous pressure, positive end-expiratory pressure, robot surgery