Clinical trial NCT02886546: Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 42
Sex: MALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many advantages, including a reduced need for blood transfusion and fewer surgical complications compared with conventional open prostatectomy. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important.

Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are used to predict and guide fluid therapy during controlled ventilation. These variables arise from heart-lung interactions during positive pressure ventilation, which influence left ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. A recent study established that PPV and SVV derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness during laparoscopic surgery.

The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse contour analysis, which is quickly and easily calibrated from the Doppler signal. We hypothesized that PPV and SVV measured by calibrated pulse contour analysis would be a good indicator of fluid responsiveness during laparoscopy with pneumoperitoneum.

The primary objective of this study was to demonstrate that PPV and SVV measured by calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid responsiveness during RALP, which involves both pneumoperitoneum and the Trendelenburg position. Investigators also assessed the capacity of other dynamic variables (SPV \[systolic pressure variation\], and SVV determined by ODM Doppler flow, dynamic elastance \[PPV/SVV\] and corrected flow time \[FTc\]) to predict fluid responsiveness during RALP.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

* patients with a BMI \> 30 or , \< 15 kg/m2 valvular heart disease left ventricular ejection fraction \< 50% a history of lung disease preoperative arrhythmia contraindications to OED monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)

Primary outcomes:
measure: SVV (stroke volume variation)
timeFrame: Measurements were performed before and after volume expansion during pneumoperitoneum
measure: PPV (pulse pressure variation)
timeFrame: Measurements were performed before and after volume expansion during pneumoperitoneum
Secondary outcomes:
measure: SPV (systolic pressure variation)
timeFrame: Measurements were performed before and after volume expansion during pneumoperitoneum
measure: SVV_flow
timeFrame: Measurements were performed before and after volume expansion during pneumoperitoneum
measure: Dynamic elastance
timeFrame: Measurements were performed before and after volume expansion during pneumoperitoneum
measure: FTc (corrected flow time)
timeFrame: Measurements were performed before and after volume expansion during pneumoperitoneum
Other outcomes:
Locations:
Study officials:
affiliation: Hallym University
name: Joohyun Jun, MD
role: STUDY_DIRECTOR
References: