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TerminatedNCT02886546Updated Jan 30, 2026

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

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

Why this study was terminated
Study terminated due to lack of efficacy based on interim analysis
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
55 Years to 80 Years
Sex
Male
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Study 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.

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

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.

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Lead sponsor

Hallym University Kangnam Sacred Heart Hospital is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing elective robot-assisted laparoscopic prostatectomy

Exclusion criteria

Exclusion Criteria:

  • patients with a > 30 or , \< 15 kg/m2 valvular heart disease \< 50% a history of lung disease preoperative arrhythmia 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)
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Interventions

  • Procedurepneumoperitoneum
  • Deviceoesophageal Doppler monitor

    Also known as: CardioQ-ODM+

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What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. SPV (systolic pressure variation)

    Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum

  2. SVV_flow

    determined by ODM Doppler flow

    Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum

  3. Dynamic elastance

    PPV/SVV

    Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum

  4. FTc (corrected flow time)

    Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2016 to primary completion in Sep 2017, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2016
First posted
Sep 1, 2016
StartActual
Sep 1, 2016
Primary completionActual
Sep 1, 2017
CompletionActual
Sep 1, 2017
Last update
Jan 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02886546
Lead sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible party
Jun joohyun (Assistant Professor, Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Hallym University Kangnam Sacred Heart Hospital) — Principal investigator
First posted
Sep 1, 2016
Start date
Sep 1, 2016
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Last update
Jan 30, 2026

Study contacts

Joohyun Jun, MD
study director · Hallym University
View the source record on ClinicalTrials.gov ↗

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