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

Primary Purpose

Cerebral Ischemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
zero end-expiratory pressure
positive end expiratory pressure
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Ischemia focused on measuring cerebral oxymetry, laparoscopy, PEEP

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gachon University Gil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

zero end-expiratory pressure

positive end expiratory pressure

Arm Description

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,

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,

Outcomes

Primary Outcome Measures

cerebral ischemia
induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record

Secondary Outcome Measures

Full Information

First Posted
September 15, 2011
Last Updated
August 8, 2013
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01436812
Brief Title
Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
Official Title
International Reveiw Board of Gachon Univerity Gil Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).
Detailed Description
The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia
Keywords
cerebral oxymetry, laparoscopy, PEEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zero end-expiratory pressure
Arm Type
Placebo Comparator
Arm Description
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,
Arm Title
positive end expiratory pressure
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
zero end-expiratory pressure
Other Intervention Name(s)
ZEEP
Intervention Description
positive end expiratory pressure 0 cm H2O during peumoperitoneum
Intervention Type
Procedure
Intervention Name(s)
positive end expiratory pressure
Other Intervention Name(s)
ZEEP
Intervention Description
PEEP 0 cmH2O
Primary Outcome Measure Information:
Title
cerebral ischemia
Description
induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record
Time Frame
change from baseline in rSO2 at every events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Jeong Kwak, MD.PhD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Youn Yi Jo, MD.PhD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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