Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation

NCT ID: NCT02512120

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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volume controlled ventilation

Randomized 23 patients will be applied VCV during RALP.

Group Type EXPERIMENTAL

volume controlled ventilation

Intervention Type DEVICE

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 ventilation

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

Group Type ACTIVE_COMPARATOR

autoflow-volume controlled ventilation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* cardiovascular disease, cerebrovascular disease, pulmonary disease
* over BMI 30
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hye-Won Shin

Director, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hye-Won Shin, MD, PhD

Role: STUDY_DIRECTOR

Department of anesthesiology and pain medicine, Korea University Anam Hospital

Other Identifiers

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Autoflow46

Identifier Type: -

Identifier Source: org_study_id

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