Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
International Reveiw Board of Gachon Univerity Gil Hospital
1 other identifier
interventional
30
1 country
1
Brief Summary
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 12, 2013
August 1, 2013
1 year
September 15, 2011
August 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cerebral ischemia
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
Study Arms (2)
zero end-expiratory pressure
PLACEBO COMPARATORnot 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,
positive end expiratory pressure
ACTIVE COMPARATORapplying 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,
Interventions
positive end expiratory pressure 0 cm H2O during peumoperitoneum
PEEP 0 cmH2O
Eligibility Criteria
You may qualify if:
- ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position
You may not qualify if:
- Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index \> 30) were excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gachon University Gil Hospital
Incheon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 20, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
June 1, 2013
Last Updated
August 12, 2013
Record last verified: 2013-08