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NCT Number: NCT02977143

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid loading of volulyte 300 ml

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. cardiac index

    Time frame: one hour after the initiation of pneumoperitoneum

    T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero

  3. 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

  4. abdominal pressure

    Time frame: one hour after the initiation of pneumoperitoneum

    T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero

  5. 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

  6. cardiac index

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

    T2: measurement of cardiac index

  7. stroke volume variation

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

    T2: measurement of stroke volume variation

  8. abdominal pressure

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

    T2: measurement of abdominal pressure

  9. 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

  10. 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

  11. 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

  12. 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

  13. central venous pressure

    Time frame: T4: 5 minutes after administration of volulyte 300 ml

    measurement of central venous pressure after fluid administration

  14. cardiac index

    Time frame: T4: 5 minutes after administration of volulyte 300 ml

    measurement of cardiac index after fluid administration

  15. stroke volume variation

    Time frame: T4: 5 minutes after administration of volulyte 300 ml

    measurement of stroke volume variation after fluid administration

  16. abdominal pressure

    Time frame: T4: 5 minutes after administration of volulyte 300 ml

    measurement of abdominal pressure after fluid administration

  17. arterial oxygen partial pressure (mmHg)

    Time frame: 5 minutes after anesthesia induction

    arterial blood gas analysis

  18. arterial carbon dioxide partial pressure (mmHg)

    Time frame: 5 minutes after anesthesia induction

    arterial blood gas analysis

  19. arterial oxygen partial pressure (mmHg)

    Time frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O

    arterial blood gas analysis

  20. 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

  21. arterial oxygen partial pressure (mmHg)

    Time frame: 1 minutes after the start of skin closure

    arterial blood gas analysis

  22. arterial carbon dioxide partial pressure (mmHg)

    Time frame: 1 minutes after the start of skin closure

    arterial blood gas analysis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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