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Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation (VCVAFVCV)

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
volume controlled ventilation
autoflow-volume controlled ventilation
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (age 19-65)
  • American Society of Anesthesiology Classification I-III

Exclusion Criteria:

  • cardiovascular disease, cerebrovascular disease, pulmonary disease
  • over BMI 30

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    volume controlled ventilation

    autoflow-volume controlled ventilation

    Arm Description

    Randomized 23 patients will be applied VCV during RALP.

    Randomized 23 patients will be applied autoflow-VCV during RALP.

    Outcomes

    Primary Outcome Measures

    Airway pressure
    Airway pressure will be measured under specified ventilation mode.

    Secondary Outcome Measures

    Vital sign
    Vital sign will be measured under specified ventilation mode.

    Full Information

    First Posted
    July 29, 2015
    Last Updated
    April 26, 2016
    Sponsor
    Korea University Anam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02512120
    Brief Title
    Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation
    Acronym
    VCVAFVCV
    Official Title
    Comparison of Volume Controlled Ventilation(VCV) vs Autoflow-volume Controlled Ventilation(Autoflow-VCV) During Robot-assisted Laparoscopic Radical Prostatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The backgroud of this study was not well discussed.
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Anam Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Volume controlled ventilation(VCV) is a most common used ventilation mode during general anesthesia. But VCV can cause high airway peak pressure when patient under steep Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.
    Detailed Description
    Robot assisted laparoscopic radical prostatectomy(RALP) has been used to treatment of prostate cancer since 2001. RALP offers some advantage such as reduced blood loss, sparing nerves, less postoperative pain. However, RALP require steep Trendelenberg position with pneumoperitoneum. It can cause increased airway peak pressure and unwanted hemodynamic effect under conventional volume controlled ventilation(VCV). Autoflow-VCV use decelerating flow, can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV 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
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    volume controlled ventilation
    Arm Type
    Experimental
    Arm Description
    Randomized 23 patients will be applied VCV during RALP.
    Arm Title
    autoflow-volume controlled ventilation
    Arm Type
    Active Comparator
    Arm Description
    Randomized 23 patients will be applied autoflow-VCV during RALP.
    Intervention Type
    Device
    Intervention Name(s)
    volume controlled ventilation
    Intervention Description
    After induction of anesthesia and intubation, patients will be applied VCV by Zeus®(Dräger, Germany). - Tidal volume : 8ml/kg(ieal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used.
    Intervention Type
    Device
    Intervention Name(s)
    autoflow-volume controlled ventilation
    Intervention Description
    After induction of anesthesia and intubation, patients will be applied autoflow- VCV by Zeus®(Dräger, Germany). - Tidal volume : 8ml/kg(ideal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used.
    Primary Outcome Measure Information:
    Title
    Airway pressure
    Description
    Airway pressure will be measured under specified ventilation mode.
    Time Frame
    4hours
    Secondary Outcome Measure Information:
    Title
    Vital sign
    Description
    Vital sign will be measured under specified ventilation mode.
    Time Frame
    4hours
    Other Pre-specified Outcome Measures:
    Title
    Arterial blood gas analysis
    Description
    Arterial blood gas analysis will be measured under specified ventilation mode.
    Time Frame
    4hours

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult (age 19-65) American Society of Anesthesiology Classification I-III Exclusion Criteria: cardiovascular disease, cerebrovascular disease, pulmonary disease over BMI 30
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hye-Won Shin, MD, PhD
    Organizational Affiliation
    Department of anesthesiology and pain medicine, Korea University Anam Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation

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