Effects of PEEP on Optic Nerve Sheath Diameter During Rob... | NCT02516566

Studies
Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy

NCT02516566

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

38Actual

Phase

Not Applicable

Conditions

Other Surgical Procedures

Interventions

PEEP

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Aug 3, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed Description

Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEEP group	Experimental	Mechanical ventilation with PEEP 8 cmH2O	Other: PEEP
No PEEP group	No Intervention	Mechanical ventilation with no PEEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEEP	Other	Mechanical ventilation with PEEP 8 cmH2O	PEEP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optic nerve sheath diameter		intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Peak airway pressure		intraoperative
Arterial blood pressure		intraoperative
Heart rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

Patients who have cerebrovascular disease or history of cerebrovascular disease
Patients who are younger than 20 years

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-Kug Kim, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28107408	Derived	Chin JH, Kim WJ, Lee J, Han YA, Lim J, Hwang JH, Cho SS, Kim YK. Effect of Positive End-Expiratory Pressure on the Sonographic Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Controlled Trial. PLoS One. 2017 Jan 20;12(1):e0170369. doi: 10.1371/journal.pone.0170369. eCollection 2017.