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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

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date January 25, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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®
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Official Title  ICMJE Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Procedure: PEEP group
    Application of 5cmH20 positive end expiratory pressure
  • Procedure: ZEEP group
    No application of positive end expiratory pressure
Study Arms  ICMJE
  • Experimental: PEEP group
    Application of 5 cmH2O PEEP during mechanical ventilation
    Intervention: Procedure: PEEP group
  • Active Comparator: ZEEP group
    No application of PEEP during mechanical ventilation
    Intervention: Procedure: ZEEP group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031613
Other Study ID Numbers  ICMJE 3-2016-0263
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dong Woo Han, Gangnam Severance Hospital
Study Sponsor  ICMJE Gangnam Severance Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dong Woo Han Gangnam Severance Hospital
PRS Account Gangnam Severance Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP