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

NCT02977143 | Completed DMC

• 1 other identifier: 1609-101-793
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm; Urinary Bladder Neoplasm

Keywords

fluid responsiveness; central venous pressure; positive end-expiratory pressure; robot surgery

Outcome Measures

Primary Outcomes (1)

• fluid responsiveness

  fluid responsiveness is determined when increase in cardiac index is more than 10%

  5 minutes after administration of 300 ml volulyte

Secondary Outcomes (22)

• central venous pressure

  one hour after the initiation of pneumoperitoneum

• cardiac index

  one hour after the initiation of pneumoperitoneum

• stroke volume variation

  one hour after the initiation of pneumoperitoneum

• abdominal pressure

  one hour after the initiation of pneumoperitoneum

• central venous pressure

  5 minutes after the application of positive end-expiratory pressure of 10 cmH2O

Study Arms (1)

Fluid responsiveness test

EXPERIMENTAL

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

Interventions

Fluid loading of volulyte 300 ml PROCEDURE

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

Fluid responsiveness test

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy.
• American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: November 30, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)