Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy

April 15, 2016 updated by: Seoul National University Hospital
This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Ah-young Oh

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60~80 yr
  • American Society of Anesthesiologists physical status 1 or 2
  • scheduled for elective robotic assisted radical prostatectomy

Exclusion Criteria:

  • heavy smoker
  • severe respiratory or cardiac disease
  • hepatic or renal function impairment
  • neurologic disease
  • BMI > 31kg/m2

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: recruitment maneuver and PEEP
apply recruitment maneuver and positive end expiratory pressure (PEEP) 5 centimeter of water (cmH2O) after induction of anesthesia
Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only
application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group
Active Comparator: PEEP
apply positive end expiratory pressure (PEEP) 5 cmH2O after induction of anesthesia
Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only
application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of perioperative complication
Time Frame: perioperative period
check the rate of perioperative complication( desaturation during operation and postoperative atelectasis in each groups
perioperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory index
Time Frame: intraoperative respiratory index
static & dynamic compliance, results of arterial blood gas analysis
intraoperative respiratory index

Collaborators and Investigators

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

Sponsor

Seoul National University 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

November 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • B-1306/206-004

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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