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

NCT ID: NCT01436812

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Cerebral Ischemia

Keywords

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cerebral oxymetry laparoscopy PEEP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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,

Group Type PLACEBO_COMPARATOR

positive end expiratory pressure

Intervention Type PROCEDURE

PEEP 0 cmH2O

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,

Group Type ACTIVE_COMPARATOR

zero end-expiratory pressure

Intervention Type PROCEDURE

positive end expiratory pressure 0 cm H2O during peumoperitoneum

Interventions

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zero end-expiratory pressure

positive end expiratory pressure 0 cm H2O during peumoperitoneum

Intervention Type PROCEDURE

positive end expiratory pressure

PEEP 0 cmH2O

Intervention Type PROCEDURE

Other Intervention Names

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ZEEP ZEEP

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Youn Yi Jo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Jeong Kwak, MD.PhD

Role: STUDY_CHAIR

Gachon University Gil Medical Center

Youn Yi Jo, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

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Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GIRBA2551

Identifier Type: REGISTRY

Identifier Source: secondary_id

GIRBA2551

Identifier Type: -

Identifier Source: org_study_id