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

NCT ID: NCT02977143

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-03-31

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.

Conditions

Prostatic Neoplasm; Urinary Bladder Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fluid responsiveness test

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.

Group Type: EXPERIMENTAL

Fluid loading of volulyte 300 ml

Intervention Type: PROCEDURE

Administration of volulyte 300 ml and measurement of increase in cardiac index

Interventions

Fluid loading of volulyte 300 ml

Administration of volulyte 300 ml and measurement of increase in cardiac index

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Won Ho Kim, MD

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1609-101-793

Identifier Type: -

Identifier Source: org_study_id