NCT02516566

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1 month

First QC Date

August 3, 2015

Last Update Submit

November 30, 2015

Conditions

Other Surgical Procedures

Keywords

Positive end-expiratory pressure ventilationOptic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter

    intraoperative

Secondary Outcomes (4)

  • Peak airway pressure

    intraoperative

  • Arterial blood pressure

    intraoperative

  • Heart rate

    intraoperative

  • Arterial carbon dioxide tension

    intraoperative

Study Arms (2)

PEEP group

EXPERIMENTAL

Mechanical ventilation with PEEP 8 cmH2O

Other: PEEP

No PEEP group

NO INTERVENTION

Mechanical ventilation with no PEEP

Interventions

PEEPOTHER

Mechanical ventilation with PEEP 8 cmH2O

PEEP group

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28107408DERIVED

Study Officials

  • Young-Kug Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 6, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11