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Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

NCT ID: NCT03202953

Last Updated: 2018-05-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-04

Study Completion Date

2018-01-24

Brief Summary

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The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy

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Detailed Description

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Conditions

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Robot Assisted Laparoscopic Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. 1:1 I:E ratio VCV group
2. autoflow VCV group
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
participants, investicator, outcome assessors will be blinded for group allocation.

Study Groups

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1:1 I:E ratio VCV (Group I)

volume controlled ventilation with 1:1 inspiratory to expiratory ratio After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

Group Type EXPERIMENTAL

ventilation strategy 1

Intervention Type PROCEDURE

In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV.

* Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

autoflow VCV (Group A)

autoflow volume-controlled ventilation After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

Group Type ACTIVE_COMPARATOR

ventilation strategy 2

Intervention Type PROCEDURE

In group A, after trendelenburg position, patients will be applied autoflow VCV.

\- Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

Interventions

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ventilation strategy 1

In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV.

* Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

Intervention Type PROCEDURE

ventilation strategy 2

In group A, after trendelenburg position, patients will be applied autoflow VCV.

\- Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. adult (20-80 years old)
2. patients undergoing robot assisted laparoscopic prostatectomy

Exclusion Criteria

1. history of COPD
2. decreased heart function (EF \<50%)
3. BMI\>30
4. patients who cannot read the consent form (e.g., blind, foreigner)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2017-0400

Identifier Type: -

Identifier Source: org_study_id

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