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

Prostatic Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977143
• Other study ID #: 1609-101-793
• Status: Completed
• Phase: N/A
• First received: November 27, 2016
• Last updated: April 1, 2018
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Prostatic Neoplasm
• Prostatic Neoplasms
• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid responsiveness	fluid responsiveness is determined when increase in cardiac index is more than 10%	5 minutes after administration of 300 ml volulyte
Secondary	central venous pressure	T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero	one hour after the initiation of pneumoperitoneum
Secondary	cardiac index	T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero	one hour after the initiation of pneumoperitoneum
Secondary	stroke volume variation	T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero	one hour after the initiation of pneumoperitoneum
Secondary	abdominal pressure	T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero	one hour after the initiation of pneumoperitoneum
Secondary	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
Secondary	cardiac index	T2: measurement of cardiac index	5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Secondary	stroke volume variation	T2: measurement of stroke volume variation	5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Secondary	abdominal pressure	T2: measurement of abdominal pressure	5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	central venous pressure	measurement of central venous pressure after fluid administration	T4: 5 minutes after administration of volulyte 300 ml
Secondary	cardiac index	measurement of cardiac index after fluid administration	T4: 5 minutes after administration of volulyte 300 ml
Secondary	stroke volume variation	measurement of stroke volume variation after fluid administration	T4: 5 minutes after administration of volulyte 300 ml
Secondary	abdominal pressure	measurement of abdominal pressure after fluid administration	T4: 5 minutes after administration of volulyte 300 ml
Secondary	arterial oxygen partial pressure (mmHg)	arterial blood gas analysis	5 minutes after anesthesia induction
Secondary	arterial carbon dioxide partial pressure (mmHg)	arterial blood gas analysis	5 minutes after anesthesia induction
Secondary	arterial oxygen partial pressure (mmHg)	arterial blood gas analysis	1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Secondary	arterial carbon dioxide partial pressure (mmHg)	arterial blood gas analysis	1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
Secondary	arterial oxygen partial pressure (mmHg)	arterial blood gas analysis	1 minutes after the start of skin closure
Secondary	arterial carbon dioxide partial pressure (mmHg)	arterial blood gas analysis	1 minutes after the start of skin closure