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

Prostate Cancer Clinical Trial

Official title:

Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031613
• Other study ID #: 3-2016-0263
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2017
• Last updated: January 24, 2017
• Start date: January 2017
• Est. completion date: November 2017

Study information

• Verified date: January 2017
• Source: Gangnam Severance Hospital
• Contact: Dong Woo Han
• Phone: 02-2019-3529
• Email: hanesth[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• PEEP group
Application of 5cmH20 positive end expiratory pressure
• ZEEP group
No application of positive end expiratory pressure

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Medical College Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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