Prostate CancerNCT02886546
Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy
A study testing pneumoperitoneum and oesophageal Doppler monitor in people with Prostate Cancer, run by Hallym University Kangnam Sacred Heart Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- pneumoperitoneum and oesophageal Doppler monitor
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing elective robot-assisted laparoscopic prostatectomy
Who cannot join
- 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)
About this study
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.
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- pneumoperitoneum, oesophageal Doppler monitor
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumoperitoneumProcedure or surgery
oesophageal Doppler monitorDevice
Also called CardioQ-ODM+
What is being measured
The primary outcome is the main question the study is designed to answer.
SVV (stroke volume variation)
measured by calibrated pulse contour analysis of CardioQ-ODM+
Measured: Measurements were performed before and after volume expansion during pneumoperitoneum
PPV (pulse pressure variation)
measured by calibrated pulse contour analysis of CardioQ-ODM+
Measured: Measurements were performed before and after volume expansion during pneumoperitoneum
Secondary outcomes (4)
SPV (systolic pressure variation)
Measured: Measurements were performed before and after volume expansion during pneumoperitoneum
SVV_flow
determined by ODM Doppler flow
Measured: Measurements were performed before and after volume expansion during pneumoperitoneum
Dynamic elastance
PPV/SVV
Measured: Measurements were performed before and after volume expansion during pneumoperitoneum
FTc (corrected flow time)
Measured: Measurements were performed before and after volume expansion during pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Why it stopped: Study terminated due to lack of efficacy based on interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun joohyun, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Joohyun Jun, MD, Study director, Hallym University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886546
- Sponsor's protocol ID
- 2016-06-72(701)
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2016
- Last updated
- 30 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT02886546
- Acronym / sponsor ID
- 2016-06-72(701)
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of efficacy based on interim analysis
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective robot-assisted laparoscopic prostatectomy
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumoperitoneum | Procedure or surgery | – |
| oesophageal Doppler monitorAlso: CardioQ-ODM+ | Device | – |
Primary outcome
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+
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+
4 secondary outcomes
SPV (systolic pressure variation)
Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum
SVV_flow
Time frame: Measurements were performed before and after volume expansion during pneumoperitoneum
Dynamic elastance
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
Results and safety
The study was stopped early (reason given: Study terminated due to lack of efficacy based on interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joohyun Jun, MD study director
Hallym University
Questions about this trial
What is this clinical trial studying?
A study testing pneumoperitoneum and oesophageal Doppler monitor in people with Prostate Cancer, run by Hallym University Kangnam Sacred Heart Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of efficacy based on interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVV (stroke volume variation) (time frame: Measurements were performed before and after volume expansion during pneumoperitoneum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.