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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

This study is currently recruiting participants.
Verified November 2016 by Won Ho Kim, MD, Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02977143
First Posted: November 30, 2016
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Ho Kim, MD, Seoul National University Hospital
  Purpose
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.

Condition Intervention
Prostatic Neoplasm Urinary Bladder Neoplasm Procedure: Fluid loading of volulyte 300 ml

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Won Ho Kim, MD, Seoul National University Hospital:

Primary Outcome Measures:
  • fluid responsiveness [ Time Frame: 5 minutes after administration of 300 ml volulyte ]
    fluid responsiveness is determined when increase in cardiac index is more than 10%


Secondary Outcome Measures:
  • central venous pressure [ Time Frame: one hour after the initiation of pneumoperitoneum ]
    T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero

  • cardiac index [ Time Frame: one hour after the initiation of pneumoperitoneum ]
    T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero

  • stroke volume variation [ Time Frame: one hour after the initiation of pneumoperitoneum ]
    T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero

  • abdominal pressure [ Time Frame: one hour after the initiation of pneumoperitoneum ]
    T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero

  • central venous pressure [ Time Frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O ]
    T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure

  • cardiac index [ Time Frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O ]
    T2: measurement of cardiac index

  • stroke volume variation [ Time Frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O ]
    T2: measurement of stroke volume variation

  • abdominal pressure [ Time Frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O ]
    T2: measurement of abdominal pressure

  • central venous pressure [ Time Frame: 5 minutes after removal of positive end-expiratory pressure ]
    T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero

  • cardiac index [ Time Frame: 5 minutes after removal of positive end-expiratory pressure ]
    T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero

  • stroke volume variation [ Time Frame: 5 minutes after removal of positive end-expiratory pressure ]
    T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero

  • abdominal pressure [ Time Frame: 5 minutes after removal of positive end-expiratory pressure ]
    T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero

  • central venous pressure [ Time Frame: T4: 5 minutes after administration of volulyte 300 ml ]
    measurement of central venous pressure after fluid administration

  • cardiac index [ Time Frame: T4: 5 minutes after administration of volulyte 300 ml ]
    measurement of cardiac index after fluid administration

  • stroke volume variation [ Time Frame: T4: 5 minutes after administration of volulyte 300 ml ]
    measurement of stroke volume variation after fluid administration

  • abdominal pressure [ Time Frame: T4: 5 minutes after administration of volulyte 300 ml ]
    measurement of abdominal pressure after fluid administration

  • arterial oxygen partial pressure (mmHg) [ Time Frame: 5 minutes after anesthesia induction ]
    arterial blood gas analysis

  • arterial carbon dioxide partial pressure (mmHg) [ Time Frame: 5 minutes after anesthesia induction ]
    arterial blood gas analysis

  • arterial oxygen partial pressure (mmHg) [ Time Frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O ]
    arterial blood gas analysis

  • arterial carbon dioxide partial pressure (mmHg) [ Time Frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O ]
    arterial blood gas analysis

  • arterial oxygen partial pressure (mmHg) [ Time Frame: 1 minutes after the start of skin closure ]
    arterial blood gas analysis

  • arterial carbon dioxide partial pressure (mmHg) [ Time Frame: 1 minutes after the start of skin closure ]
    arterial blood gas analysis


Estimated Enrollment: 49
Study Start Date: November 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977143


Contacts
Contact: Won Ho Kim, MD,PhD 82-2-2072-2460 ext 2462 wonhokim.ane@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Won Ho Kim, MD,PhD    82-2-2072-2460 ext 2462    wonhokim.ane@gmail.com   
Contact: Min Hur, MD    82-2-2072-2460 ext 2460    nuage1220@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02977143     History of Changes
Other Study ID Numbers: 1609-101-793
First Submitted: November 27, 2016
First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Won Ho Kim, MD, Seoul National University Hospital:
fluid responsiveness
central venous pressure
positive end-expiratory pressure
robot surgery

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Urinary Bladder Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases