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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

Primary Purpose

Robot Assisted Laparoscopic Prostatectomy

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ventilation strategy 1

ventilation strategy 2

About this trial

This is an interventional prevention trial for Robot Assisted Laparoscopic Prostatectomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

history of COPD
decreased heart function (EF <50%)
BMI>30
patients who cannot read the consent form (e.g., blind, foreigner)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

autoflow VCV (Group A)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PaO2

PaO2 analyzed by arterial blood gas analysis

Secondary Outcome Measures

PaO2

End tidal CO2

peak airway pressure

blood pressure

Arterial blood gas analysis

pH, SaO2, Base excess

Full Information

NCT ID

NCT03202953

First Posted

June 26, 2017

Last Updated

May 17, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03202953

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

July 4, 2017 (Actual)

Primary Completion Date

January 24, 2018 (Actual)

Study Completion Date

January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Robot Assisted Laparoscopic Prostatectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1 I:E ratio VCV group autoflow VCV group

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

participants, investicator, outcome assessors will be blinded for group allocation.

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

autoflow VCV (Group A)

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ventilation strategy 1

Intervention Description

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

Intervention Name(s)

ventilation strategy 2

Intervention Description

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.

Primary Outcome Measure Information:

Title

PaO2

Description

PaO2 analyzed by arterial blood gas analysis

Time Frame

30 minutes after trendelenburg position

Secondary Outcome Measure Information:

Title

PaO2

Time Frame