Clinical trial NCT02977143: Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Urinary Bladder Neoplasm
Keywords: fluid responsiveness
central venous pressure
positive end-expiratory pressure
robot surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: fluid responsiveness
timeFrame: 5 minutes after administration of 300 ml volulyte
Secondary outcomes:
measure: central venous pressure
timeFrame: one hour after the initiation of pneumoperitoneum
measure: cardiac index
timeFrame: one hour after the initiation of pneumoperitoneum
measure: stroke volume variation
timeFrame: one hour after the initiation of pneumoperitoneum
measure: abdominal pressure
timeFrame: one hour after the initiation of pneumoperitoneum
measure: central venous pressure
timeFrame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
measure: cardiac index
timeFrame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
measure: stroke volume variation
timeFrame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
measure: abdominal pressure
timeFrame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
measure: central venous pressure
timeFrame: 5 minutes after removal of positive end-expiratory pressure
measure: cardiac index
timeFrame: 5 minutes after removal of positive end-expiratory pressure
measure: stroke volume variation
timeFrame: 5 minutes after removal of positive end-expiratory pressure
measure: abdominal pressure
timeFrame: 5 minutes after removal of positive end-expiratory pressure
measure: central venous pressure
timeFrame: T4: 5 minutes after administration of volulyte 300 ml
measure: cardiac index
timeFrame: T4: 5 minutes after administration of volulyte 300 ml
measure: stroke volume variation
timeFrame: T4: 5 minutes after administration of volulyte 300 ml
measure: abdominal pressure
timeFrame: T4: 5 minutes after administration of volulyte 300 ml
measure: arterial oxygen partial pressure (mmHg)
timeFrame: 5 minutes after anesthesia induction
measure: arterial carbon dioxide partial pressure (mmHg)
timeFrame: 5 minutes after anesthesia induction
measure: arterial oxygen partial pressure (mmHg)
timeFrame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
measure: arterial carbon dioxide partial pressure (mmHg)
timeFrame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
measure: arterial oxygen partial pressure (mmHg)
timeFrame: 1 minutes after the start of skin closure
measure: arterial carbon dioxide partial pressure (mmHg)
timeFrame: 1 minutes after the start of skin closure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: