Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Surgery in the Prone Position

March 6, 2020 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center

Long standing prone position could affect vision or optic nerve. To measure the optic nerve sheath diameter using ultrasound is quick and useful assessments of patients.

This study will look at the change of optic nerve sheath diameters of patients undergoing surgery in prone position

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing prone position surgery in out institute.

Description

Inclusion Criteria:

  • Patients undergoing surgery in prone position

Exclusion Criteria:

  • Patients who did not agree to participate in the study
  • Patients has ophthalmic diseases
  • Patients has previous history of ophthalmic surgery.
  • Patients has neurological disorders.
  • Patients has history of head surgery.
  • Severe anaphylactic allergy to ultrasound gel or Tegaderm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Prone position
Patients undergoing surgery in prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change optic nerve sheath diameter
Time Frame: 0,1,3,6,24 and 48 hours
Change in Optic nerve sheathe diameter from baseline, before surgery, immediate after surgery (prone, supine), 1,3,6,24 and 48 hours after completion of surgery
0,1,3,6,24 and 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SMG-SNU Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 20200305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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