search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP group
ZEEP group
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring intraocular pressure, intracerebral pressure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Yonsei University Medical College Gangnam Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEEP group

ZEEP group

Arm Description

Application of 5 cmH2O PEEP during mechanical ventilation

No application of PEEP during mechanical ventilation

Outcomes

Primary Outcome Measures

IOP
IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
ICP
ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound

Secondary Outcome Measures

Full Information

First Posted
January 5, 2017
Last Updated
January 24, 2017
Sponsor
Gangnam Severance Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03031613
Brief Title
Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Official Title
Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
intraocular pressure, intracerebral pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEEP group
Arm Type
Experimental
Arm Description
Application of 5 cmH2O PEEP during mechanical ventilation
Arm Title
ZEEP group
Arm Type
Active Comparator
Arm Description
No application of PEEP during mechanical ventilation
Intervention Type
Procedure
Intervention Name(s)
PEEP group
Intervention Description
Application of 5cmH20 positive end expiratory pressure
Intervention Type
Procedure
Intervention Name(s)
ZEEP group
Intervention Description
No application of positive end expiratory pressure
Primary Outcome Measure Information:
Title
IOP
Description
IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
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
Title
ICP
Description
ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound
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

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Woo Han
Phone
02-2019-3529
Email
hanesth@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Woo Han
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Medical College Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Woo Han, MD., Ph.D.
Phone
82220193529

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs