An interventional study of pneumoperitoneum and oesophageal Doppler monitor in Prostate Cancer, sponsored by Hallym University Kangnam Sacred Heart Hospital. Terminated. Open to male participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Hallym University Kangnam Sacred Heart Hospital · Not applicable, Interventional, and Screening
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Hallym University Kangnam Sacred Heart Hospital is the lead sponsor of 34 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Also known as: CardioQ-ODM+
SVV (stroke volume variation)
measured by calibrated pulse contour analysis of CardioQ-ODM+
Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum
PPV (pulse pressure variation)
measured by calibrated pulse contour analysis of CardioQ-ODM+
Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum
SPV (systolic pressure variation)
Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum
SVV_flow
determined by ODM Doppler flow
Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum
Dynamic elastance
PPV/SVV
Time frame: 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
No study locations are listed for this record.
Ran from Sep 2016 to primary completion in Sep 2017, 12 months.
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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Hallym University Kangnam Sacred Heart Hospital