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

NCT ID: NCT01443962

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Brain Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Zero positive end expiratory pressure

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

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

applying PEEP 0 cmH2O during pneumoperitoneum continuously

positive end expiratory pressure

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Group Type ACTIVE_COMPARATOR

ZEEP

Intervention Type OTHER

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Interventions

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PEEP

applying PEEP 0 cmH2O during pneumoperitoneum continuously

Intervention Type OTHER

ZEEP

applying PEEP 10 cmH2O during pneumoperitoneum continuously

Intervention Type OTHER

Other Intervention Names

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PEEP 0 PEEP 10

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jeong Kwak

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Chon Lee, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

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Hyun Jeong Kwak

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GIRBA 2568

Identifier Type: -

Identifier Source: org_study_id

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