Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
1 other identifier
interventional
50
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jan 2017
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJanuary 25, 2017
January 1, 2017
10 months
January 5, 2017
January 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
IOP
IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
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
ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound
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
Study Arms (2)
PEEP group
EXPERIMENTALApplication of 5 cmH2O PEEP during mechanical ventilation
ZEEP group
ACTIVE COMPARATORNo application of PEEP during mechanical ventilation
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing robotic-assisted laparoscopic radical prostatectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Medical College Gangnam Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Woo Han
Gangnam Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 5, 2017
First Posted
January 25, 2017
Study Start
January 1, 2017
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
January 25, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share