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

Primary Purpose

Prostatic Neoplasm, Urinary Bladder Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluid loading of volulyte 300 ml
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasm focused on measuring fluid responsiveness, central venous pressure, positive end-expiratory pressure, robot surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluid responsiveness test

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

central venous pressure
T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero
cardiac index
T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero
stroke volume variation
T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
abdominal pressure
T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
central venous pressure
T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure
cardiac index
T2: measurement of cardiac index
stroke volume variation
T2: measurement of stroke volume variation
abdominal pressure
T2: measurement of abdominal pressure
central venous pressure
T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero
cardiac index
T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero
stroke volume variation
T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
abdominal pressure
T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
central venous pressure
measurement of central venous pressure after fluid administration
cardiac index
measurement of cardiac index after fluid administration
stroke volume variation
measurement of stroke volume variation after fluid administration
abdominal pressure
measurement of abdominal pressure after fluid administration
arterial oxygen partial pressure (mmHg)
arterial blood gas analysis
arterial carbon dioxide partial pressure (mmHg)
arterial blood gas analysis
arterial oxygen partial pressure (mmHg)
arterial blood gas analysis
arterial carbon dioxide partial pressure (mmHg)
arterial blood gas analysis
arterial oxygen partial pressure (mmHg)
arterial blood gas analysis
arterial carbon dioxide partial pressure (mmHg)
arterial blood gas analysis

Full Information

First Posted
November 27, 2016
Last Updated
April 1, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02977143
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Urinary Bladder Neoplasm
Keywords
fluid responsiveness, central venous pressure, positive end-expiratory pressure, robot surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluid responsiveness test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fluid loading of volulyte 300 ml
Intervention Description
Administration of volulyte 300 ml and measurement of increase in cardiac index
Primary Outcome Measure Information:
Title
fluid responsiveness
Description
fluid responsiveness is determined when increase in cardiac index is more than 10%
Time Frame
5 minutes after administration of 300 ml volulyte
Secondary Outcome Measure Information:
Title
central venous pressure
Description
T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero
Time Frame
one hour after the initiation of pneumoperitoneum
Title
cardiac index
Description
T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero
Time Frame
one hour after the initiation of pneumoperitoneum
Title
stroke volume variation
Description
T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
Time Frame
one hour after the initiation of pneumoperitoneum
Title
abdominal pressure
Description
T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
Time Frame
one hour after the initiation of pneumoperitoneum
Title
central venous pressure
Description
T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure
Time Frame
5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Title
cardiac index
Description
T2: measurement of cardiac index
Time Frame
5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Title
stroke volume variation
Description
T2: measurement of stroke volume variation
Time Frame
5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Title
abdominal pressure
Description
T2: measurement of abdominal pressure
Time Frame
5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Title
central venous pressure
Description
T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero
Time Frame
5 minutes after removal of positive end-expiratory pressure
Title
cardiac index
Description
T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero
Time Frame
5 minutes after removal of positive end-expiratory pressure
Title
stroke volume variation
Description
T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
Time Frame
5 minutes after removal of positive end-expiratory pressure
Title
abdominal pressure
Description
T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
Time Frame
5 minutes after removal of positive end-expiratory pressure
Title
central venous pressure
Description
measurement of central venous pressure after fluid administration
Time Frame
T4: 5 minutes after administration of volulyte 300 ml
Title
cardiac index
Description
measurement of cardiac index after fluid administration
Time Frame
T4: 5 minutes after administration of volulyte 300 ml
Title
stroke volume variation
Description
measurement of stroke volume variation after fluid administration
Time Frame
T4: 5 minutes after administration of volulyte 300 ml
Title
abdominal pressure
Description
measurement of abdominal pressure after fluid administration
Time Frame
T4: 5 minutes after administration of volulyte 300 ml
Title
arterial oxygen partial pressure (mmHg)
Description
arterial blood gas analysis
Time Frame
5 minutes after anesthesia induction
Title
arterial carbon dioxide partial pressure (mmHg)
Description
arterial blood gas analysis
Time Frame
5 minutes after anesthesia induction
Title
arterial oxygen partial pressure (mmHg)
Description
arterial blood gas analysis
Time Frame
1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Title
arterial carbon dioxide partial pressure (mmHg)
Description
arterial blood gas analysis
Time Frame
1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Title
arterial oxygen partial pressure (mmHg)
Description
arterial blood gas analysis
Time Frame
1 minutes after the start of skin closure
Title
arterial carbon dioxide partial pressure (mmHg)
Description
arterial blood gas analysis
Time Frame
1 minutes after the start of skin closure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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