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

April 26, 2016 updated by: Hye-Won Shin, Korea University Anam Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: volume controlled ventilation
Randomized 23 patients will be applied VCV during RALP.
Device: volume controlled ventilation

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.
Active Comparator: autoflow-volume controlled ventilation
Randomized 23 patients will be applied autoflow-VCV during RALP.
Device: autoflow-volume controlled ventilation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway pressure
Time Frame: 4hours
Airway pressure will be measured under specified ventilation mode.
4hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital sign
Time Frame: 4hours
Vital sign will be measured under specified ventilation mode.
4hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gas analysis
Time Frame: 4hours
Arterial blood gas analysis will be measured under specified ventilation mode.
4hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Investigators

  • Study Director: Hye-Won Shin, MD, PhD, Department of anesthesiology and pain medicine, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autoflow46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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