Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy

January 28, 2026 updated by: Jun joohyun, Hallym University Kangnam Sacred Heart Hospital

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.

Study Overview

Status

Terminated

Conditions

Prostate Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Screening
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVV (stroke volume variation) Time Frame: Measurements were performed before and after volume expansion during pneumoperitoneum	measured by calibrated pulse contour analysis of CardioQ-ODM+	Measurements were performed before and after volume expansion during pneumoperitoneum
PPV (pulse pressure variation) Time Frame: Measurements were performed before and after volume expansion during pneumoperitoneum	measured by calibrated pulse contour analysis of CardioQ-ODM+	Measurements were performed before and after volume expansion during pneumoperitoneum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPV (systolic pressure variation) Time Frame: Measurements were performed before and after volume expansion during pneumoperitoneum		Measurements were performed before and after volume expansion during pneumoperitoneum
SVV_flow Time Frame: Measurements were performed before and after volume expansion during pneumoperitoneum	determined by ODM Doppler flow	Measurements were performed before and after volume expansion during pneumoperitoneum
Dynamic elastance Time Frame: Measurements were performed before and after volume expansion during pneumoperitoneum	PPV/SVV	Measurements were performed before and after volume expansion during pneumoperitoneum
FTc (corrected flow time) Time Frame: Measurements were performed before and after volume expansion during pneumoperitoneum		Measurements were performed before and after volume expansion during pneumoperitoneum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Investigators

Study Director: Joohyun Jun, MD, Hallym University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 27, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimated)