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

Primary Purpose

Brain Ischemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP
ZEEP
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Ischemia focused on measuring laparoscopic cholecystectomy, PEEP, rSO2

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hyun Jeong Kwak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero positive end expiratory pressure

positive end expiratory pressure

Arm Description

Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Outcomes

Primary Outcome Measures

change in regional brain oxygen saturation
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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2011
Last Updated
February 2, 2013
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01443962
Brief Title
The Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy
Acronym
lapaPEEP
Official Title
The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia
Keywords
laparoscopic cholecystectomy, PEEP, rSO2

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zero positive end expiratory pressure
Arm Type
Experimental
Arm Description
Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period
Arm Title
positive end expiratory pressure
Arm Type
Active Comparator
Arm Description
applying PEEP 10 cmH2O during pneumoperitoneum continuously
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
PEEP 0
Intervention Description
applying PEEP 0 cmH2O during pneumoperitoneum continuously
Intervention Type
Other
Intervention Name(s)
ZEEP
Other Intervention Name(s)
PEEP 10
Intervention Description
applying PEEP 10 cmH2O during pneumoperitoneum continuously
Primary Outcome Measure Information:
Title
change in regional brain oxygen saturation
Description
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
Time Frame
from baseline record rSO2 every 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Chon Lee, M.D., Ph.D
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hyun Jeong Kwak
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

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

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