NCT03785314

Brief Summary

Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position). This study is designed to measure the optic nerve sheath diameter in lateral decubitus and sitting position, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 24, 2020

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

December 20, 2018

Last Update Submit

February 20, 2020

Conditions

Optic Neve Sheath Diameter

Keywords

Optic Nerve Sheath Diameter Different Position

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath diameter change among 4 time period

    optic nerve sheath diameter change among 4 time period using ultrasound

    Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention

Study Arms (2)

injection under sitting position

ACTIVE COMPARATOR

saline injection under sitting position during thoracic epidural catheterization

Other: thoracic epidural catheterization

injection under lateral decubitus position

ACTIVE COMPARATOR

saline injection under lateral decubitus position during thoracic epidural catheterization

Other: thoracic epidural catheterization

Interventions

thoracic epidural catheterizationOTHER

thoracic epidural catheterization with different posture

injection under lateral decubitus positioninjection under sitting position

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung cancer
  • liver cancer
  • stomach cancer
  • pancreas cancer

You may not qualify if:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level
  • previous brain surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

Location

Study Officials

  • Ji Hee Hong, PhD

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

January 2, 2019

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

February 24, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)