Prostate CancerVCVAFVCVNCT02512120
Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation
A study of Prostate Cancer, run by Korea University Anam Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 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 19 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age 19-65)
- American Society of Anesthesiology Classification I-III
Who cannot join
- cardiovascular disease, cerebrovascular disease, pulmonary disease
- over BMI 30
About this study
Official title: Comparison of Volume Controlled Ventilation(VCV) vs Autoflow-volume Controlled Ventilation(Autoflow-VCV) During Robot-assisted Laparoscopic Radical Prostatectomy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- volume controlled ventilation, autoflow-volume controlled ventilation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume controlled ventilationDevice
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.
autoflow-volume controlled ventilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| volume controlled ventilation | Experimental | Randomized 23 patients will be applied VCV during RALP. Receives: Device: volume controlled ventilation |
| autoflow-volume controlled ventilation | Active comparator | Randomized 23 patients will be applied autoflow-VCV during RALP. Receives: Device: autoflow-volume controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway pressure
Airway pressure will be measured under specified ventilation mode.
Measured: 4hours
Secondary outcomes (1)
Vital sign
Vital sign will be measured under specified ventilation mode.
Measured: 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The backgroud of this study was not well discussed.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye-Won Shin, Korea University Anam Hospital
- Investigators
- Hye-Won Shin, MD, PhD, Study director, Department of anesthesiology and pain medicine, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512120
- Sponsor's protocol ID
- Autoflow46
- Acronym
- VCVAFVCV
- Status last verified
- Apr 2016
- First submitted
- 29 Jul 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Volume Controlled Ventilation(VCV) vs Autoflow-volume Controlled Ventilation(Autoflow-VCV) During Robot-assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02512120
- Acronym / sponsor ID
- VCVAFVCV / Autoflow46
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The backgroud of this study was not well discussed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Jul 2015 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volume controlled ventilation | Experimental | Device: volume controlled ventilationRandomized 23 patients will be applied VCV during RALP. |
| autoflow-volume controlled ventilation | Active comparator | Device: autoflow-volume controlled ventilationRandomized 23 patients will be applied autoflow-VCV during RALP. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (age 19-65)
- American Society of Anesthesiology Classification I-III
Key exclusion criteria (2 listed)
- cardiovascular disease, cerebrovascular disease, pulmonary disease
- over BMI 30
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 |
|---|---|---|
| volume controlled ventilationAfter 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. | Device | volume controlled ventilation |
| autoflow-volume controlled ventilationAfter 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. | Device | autoflow-volume controlled ventilation |
Primary outcome
Airway pressure
Time frame: 4hours
Airway pressure will be measured under specified ventilation mode.
1 secondary outcome
Vital sign
Time frame: 4hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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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.
Hye-Won Shin, MD, PhD study director
Department of anesthesiology and pain medicine, Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
A study of Prostate Cancer, run by Korea University Anam 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 27 Apr 2016. 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 withdrawn before enrolling participants, so there are no results.
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?
Airway pressure (time frame: 4hours). 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 27 Apr 2016.