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NCT01436812 Clinical Trial

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

Cerebral Ischemia Clinical Trial

Official title:
International Reveiw Board of Gachon Univerity Gil Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01436812
Other study ID # GIRBA2551
Secondary ID GIRBA2551
Status Completed
Phase N/A
First received September 15, 2011
Last updated August 8, 2013
Start date September 2011
Est. completion date June 2013

Study information
Verified date August 2013
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2013
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• zero end-expiratory pressure
positive end expiratory pressure 0 cm H2O during peumoperitoneum
• positive end expiratory pressure
PEEP 0 cmH2O

Locations
Country Name City State
Korea, Republic of Gachon University Gil Hospital Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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