The Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy (lapaPEEP)

February 2, 2013 updated by: Hyun Jeong Kwak, Gachon University Gil Medical Center

The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy

During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain due to increased intracranial pressure, central venous pressure and make worse to respiratory parameters. Positive end expiratory pressure could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional oxygen saturation of brain during the pneumoperitoneum during the laparoscopic cholecystectomy.

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

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I or II,
  • 20-65 year,
  • patient who undergoing laparoscopic cholecystectomy

Exclusion Criteria:

  • cerebrovascular disease,
  • coronary artery disease,
  • morbid obesity (BMI > 30)
  • propofol allergy,
  • addictive

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zero positive end expiratory pressure
Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period
Other: PEEP
applying PEEP 0 cmH2O during pneumoperitoneum continuously
Other Names:
  • PEEP 0
Active Comparator: positive end expiratory pressure
applying PEEP 10 cmH2O during pneumoperitoneum continuously
Other: ZEEP
applying PEEP 10 cmH2O during pneumoperitoneum continuously
Other Names:
  • PEEP 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in regional brain oxygen saturation
Time Frame: from baseline record rSO2 every 10 minutes
FiO2 0.6, Tidal vlume 8 ml/IBW (kg), PEEP 10 cm H2O or not, respiratory rate as end-tidal carbone dioxide concentration (ETCO2). During the peumoperitoneum record rSO2 every 10 minutes with respiratory parameters (Peak pressure, mean pressure, PEEP) and vital signs
from baseline record rSO2 every 10 minutes

Collaborators and Investigators

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

Sponsor

Gachon University Gil Medical Center

Investigators

  • Principal Investigator: Kyung Chon Lee, M.D., Ph.D, 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

November 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 2, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRBA 2568

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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