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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031613
Recruitment Status : Unknown
Verified January 2017 by Dong Woo Han, Gangnam Severance Hospital.
Recruitment status was:  Recruiting
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Dong Woo Han, Gangnam Severance Hospital

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: PEEP group Procedure: ZEEP group Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Study Start Date : January 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEEP group
Application of 5 cmH2O PEEP during mechanical ventilation
Procedure: PEEP group
Application of 5cmH20 positive end expiratory pressure

Active Comparator: ZEEP group
No application of PEEP during mechanical ventilation
Procedure: ZEEP group
No application of positive end expiratory pressure




Primary Outcome Measures :
  1. IOP [ Time Frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min ]
    IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®

  2. ICP [ Time Frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min ]
    ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031613


Contacts
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Contact: Dong Woo Han 02-2019-3529 hanesth@yuhs.ac

Locations
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Korea, Republic of
Yonsei University Medical College Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Woo Han, MD., Ph.D.    82220193529      
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
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Principal Investigator: Dong Woo Han Gangnam Severance Hospital
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Responsible Party: Dong Woo Han, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03031613    
Other Study ID Numbers: 3-2016-0263
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dong Woo Han, Gangnam Severance Hospital:
intraocular pressure
intracerebral pressure
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases