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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pneumoperitoneum
oesophageal Doppler monitor
Sponsored by
Hallym University Kangnam Sacred Heart Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    SVV (stroke volume variation)
    measured by calibrated pulse contour analysis of CardioQ-ODM+
    PPV (pulse pressure variation)
    measured by calibrated pulse contour analysis of CardioQ-ODM+

    Secondary Outcome Measures

    SPV (systolic pressure variation)
    SVV_flow
    determined by ODM Doppler flow
    Dynamic elastance
    PPV/SVV
    FTc (corrected flow time)

    Full Information

    First Posted
    August 27, 2016
    Last Updated
    September 10, 2016
    Sponsor
    Hallym University Kangnam Sacred Heart Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02886546
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hallym University Kangnam Sacred Heart Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    pneumoperitoneum
    Intervention Type
    Device
    Intervention Name(s)
    oesophageal Doppler monitor
    Other Intervention Name(s)
    CardioQ-ODM+
    Primary Outcome Measure Information:
    Title
    SVV (stroke volume variation)
    Description
    measured by calibrated pulse contour analysis of CardioQ-ODM+
    Time Frame
    Measurements were performed before and after volume expansion during pneumoperitoneum
    Title
    PPV (pulse pressure variation)
    Description
    measured by calibrated pulse contour analysis of CardioQ-ODM+
    Time Frame
    Measurements were performed before and after volume expansion during pneumoperitoneum
    Secondary Outcome Measure Information:
    Title
    SPV (systolic pressure variation)
    Time Frame
    Measurements were performed before and after volume expansion during pneumoperitoneum
    Title
    SVV_flow
    Description
    determined by ODM Doppler flow
    Time Frame
    Measurements were performed before and after volume expansion during pneumoperitoneum
    Title
    Dynamic elastance
    Description
    PPV/SVV
    Time Frame
    Measurements were performed before and after volume expansion during pneumoperitoneum
    Title
    FTc (corrected flow time)
    Time Frame
    Measurements were performed before and after volume expansion during pneumoperitoneum

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joohyun Jun, MD
    Phone
    +82-10-8864-7731
    Email
    ilpleut@hallym.or.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joohyun Jun, MD
    Organizational Affiliation
    Hallym University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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