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Withdrawn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
About this trial
This is an interventional supportive care trial for Prostate Cancer
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
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
NCT ID
NCT02512120
First Posted
July 29, 2015
Last Updated
April 26, 2016
Sponsor
Korea University Anam Hospital
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Withdrawn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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