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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Jeong Kwak, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01443962
First received: September 27, 2011
Last updated: February 2, 2013
Last verified: February 2013
  Purpose

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 Intervention
Brain Ischemia
Other: PEEP
Other: ZEEP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • change in regional brain oxygen saturation [ Time Frame: from baseline record rSO2 every 10 minutes ] [ Designated as safety issue: No ]
    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


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
  More Information

No publications provided

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
Study First Received: September 27, 2011
Last Updated: February 2, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
laparoscopic cholecystectomy
PEEP
rSO2

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

ClinicalTrials.gov processed this record on September 18, 2014