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

September 15, 2011
August 8, 2013
September 2011
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01436812 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
International Reveiw Board of Gachon Univerity Gil Hospital

The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Cerebral Ischemia
  • Procedure: zero end-expiratory pressure
    positive end expiratory pressure 0 cm H2O during peumoperitoneum
    Other Name: ZEEP
  • Procedure: positive end expiratory pressure
    PEEP 0 cmH2O
    Other Name: ZEEP
  • 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,
    Intervention: Procedure: positive end expiratory pressure
  • 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,
    Intervention: Procedure: zero end-expiratory pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01436812
GIRBA2551, GIRBA2551
Yes
Youn Yi Jo, Gachon University Gil Medical Center
Gachon University Gil Medical Center
Not Provided
Study Chair: Hyun Jeong Kwak, MD.PhD Gachon University Gil Hospital
Principal Investigator: Youn Yi Jo, MD.PhD Gachon University Gil Hospital
Gachon University Gil Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP