NCT04301817

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

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

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 6, 2020

Last Update Submit

March 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change optic nerve sheath diameter

    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

Study Arms (1)

Prone position

Patients undergoing surgery in prone position

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing prone position surgery in out institute.

You may qualify if:

  • Patients undergoing surgery in prone position

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.

  • Chin JH, Seo H, Lee EH, Lee J, Hong JH, Hwang JH, Kim YK. Sonographic optic nerve sheath diameter as a surrogate measure for intracranial pressure in anesthetized patients in the Trendelenburg position. BMC Anesthesiol. 2015 Mar 31;15:43. doi: 10.1186/s12871-015-0025-9. eCollection 2015.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

March 10, 2020

Record last verified: 2020-03