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

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ClinicalTrials.gov Identifier: NCT01443962
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Hyun Jeong Kwak, Gachon University Gil Medical Center

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)

Condition or disease Intervention/treatment Phase
Brain Ischemia Other: PEEP Other: ZEEP Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy
Study Start Date : November 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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 Name: 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 Name: PEEP 10



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443962


Locations
Korea, Republic of
Hyun Jeong Kwak
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Kyung Chon Lee, M.D., Ph.D Gachon University Gil Medical Center

Responsible Party: Hyun Jeong Kwak, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01443962     History of Changes
Other Study ID Numbers: GIRBA 2568
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Hyun Jeong Kwak, Gachon University Gil Medical Center:
laparoscopic cholecystectomy
PEEP
rSO2

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases