Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy

August 8, 2013 updated by: Youn Yi Jo, Gachon University Gil Medical Center

International Reveiw Board of Gachon Univerity Gil Hospital

The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.

Study Type

Interventional

Enrollment (Actual)

30

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

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position

Exclusion Criteria:

  • Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: zero end-expiratory pressure
not applying PEEP during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min,
Procedure: positive end expiratory pressure
PEEP 0 cmH2O
Other Names:
  • ZEEP
Active Comparator: positive end expiratory pressure
applying PEEP 10cmH2O during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min,
Procedure: zero end-expiratory pressure
positive end expiratory pressure 0 cm H2O during peumoperitoneum
Other Names:
  • ZEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebral ischemia
Time Frame: change from baseline in rSO2 at every events
induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record
change from baseline in rSO2 at every events

Collaborators and Investigators

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

Sponsor

Gachon University Gil Medical Center

Investigators

  • Study Chair: Hyun Jeong Kwak, MD.PhD, Gachon University Gil Medical Center
  • Principal Investigator: Youn Yi Jo, MD.PhD, Gachon University Gil Medical Center

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

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 18, 2011

First Posted (Estimate)

September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRBA2551 (Registry Identifier: IRB of Gachon University Gil Hospital)

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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