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

May 17, 2018 updated by: Yonsei University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2
Time Frame: 30 minutes after trendelenburg position
PaO2 analyzed by arterial blood gas analysis
30 minutes after trendelenburg position

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2
Time Frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
End tidal CO2
Time Frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
peak airway pressure
Time Frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
blood pressure
Time Frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Arterial blood gas analysis
Time Frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
pH, SaO2, Base excess
10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (Actual)

July 4, 2017

Primary Completion (Actual)

January 24, 2018

Study Completion (Actual)

January 24, 2018

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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