- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01436812
Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
August 8, 2013 updated by: Youn Yi Jo, Gachon University Gil Medical Center
International Reveiw Board of Gachon Univerity Gil Hospital
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Incheon, Korea, Republic of
- Gachon University Gil Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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,
|
PEEP 0 cmH2O
Other Names:
|
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,
|
positive end expiratory pressure 0 cm H2O during peumoperitoneum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
change from baseline in rSO2 at every events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
September 15, 2011
First Submitted That Met QC Criteria
September 18, 2011
First Posted (Estimate)
September 20, 2011
Study Record Updates
Last Update Posted (Estimate)
August 12, 2013
Last Update Submitted That Met QC Criteria
August 8, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIRBA2551 (Registry Identifier: IRB of Gachon University Gil Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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