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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01436812
First received: September 15, 2011
Last updated: August 8, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: International Reveiw Board of Gachon Univerity Gil Hospital

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

Primary Outcome Measures:
  • cerebral ischemia [ Time Frame: change from baseline in rSO2 at every events ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
Principal Investigator: Youn Yi Jo, MD.PhD Gachon University Gil Hospital
  More Information

No publications provided

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
Study First Received: September 15, 2011
Last Updated: August 8, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
cerebral oxymetry
laparoscopy
PEEP

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

ClinicalTrials.gov processed this record on August 28, 2014