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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm; Urinary Bladder Neoplasm
• Intervention / Treatment: Procedure: Fluid loading of volulyte 300 ml

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Fluid loading of volulyte 300 ml; Administration of volulyte 300 ml and measurement of increase in cardiac index

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: November 27, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: April 1, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: fluid responsiveness; central venous pressure; positive end-expiratory pressure; robot surgery
• Additional Relevant MeSH Terms: Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Genital Neoplasms, Male; Prostatic Diseases; Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: 1609-101-793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO