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Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436812
First Posted: September 20, 2011
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center
  Purpose
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).

Condition Intervention
Cerebral Ischemia Procedure: zero end-expiratory pressure Procedure: positive end expiratory pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: International Reveiw Board of Gachon Univerity Gil Hospital

Further study details as provided by Youn Yi Jo, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • cerebral ischemia [ Time Frame: change from baseline in rSO2 at every events ]
    induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record


Enrollment: 30
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: zero end-expiratory pressure
not applying PEEP during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min,
Procedure: positive end expiratory pressure
PEEP 0 cmH2O
Other Name: ZEEP
Active Comparator: positive end expiratory pressure
applying PEEP 10cmH2O during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min,
Procedure: zero end-expiratory pressure
positive end expiratory pressure 0 cm H2O during peumoperitoneum
Other Name: ZEEP

Detailed Description:
The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position

Exclusion Criteria:

  • Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.
  Contacts and Locations
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): NCT01436812


Locations
Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Study Chair: Hyun Jeong Kwak, MD.PhD Gachon University Gil Medical Center
Principal Investigator: Youn Yi Jo, MD.PhD Gachon University Gil Medical Center
  More Information

Responsible Party: Youn Yi Jo, Assistant professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01436812     History of Changes
Other Study ID Numbers: GIRBA2551
GIRBA2551 ( Registry Identifier: IRB of Gachon University Gil Hospital )
First Submitted: September 15, 2011
First Posted: September 20, 2011
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Youn Yi Jo, Gachon University Gil Medical Center:
cerebral oxymetry
laparoscopy
PEEP

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