Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy

NCT ID: NCT03031613

Last Updated: 2017-01-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-11-30

Brief Summary

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To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)

Detailed Description

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Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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PEEP group

Application of 5 cmH2O PEEP during mechanical ventilation

Group Type EXPERIMENTAL

PEEP group

Intervention Type PROCEDURE

Application of 5cmH20 positive end expiratory pressure

ZEEP group

No application of PEEP during mechanical ventilation

Group Type ACTIVE_COMPARATOR

ZEEP group

Intervention Type PROCEDURE

No application of positive end expiratory pressure

Interventions

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PEEP group

Application of 5cmH20 positive end expiratory pressure

Intervention Type PROCEDURE

ZEEP group

No application of positive end expiratory pressure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing robotic-assisted laparoscopic radical prostatectomy

Exclusion Criteria

* History of opthalmic disease or surgery
* History of brain disease or surgery
* Known ICP elevation
* Known IOP elevation
* Presence of lung bullae on chest x-ray
* History of pneumothorax
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Woo Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Woo Han

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Locations

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Yonsei University Medical College Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Woo Han

Role: CONTACT

02-2019-3529

Facility Contacts

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Dong Woo Han, MD., Ph.D.

Role: primary

82220193529

Other Identifiers

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3-2016-0263

Identifier Type: -

Identifier Source: org_study_id

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