Change of Optic Nerve Sheath Diameter After Deflation of Pneumatic Tourniquet

December 19, 2018 updated by: Hajung Kim, Asan Medical Center

Effect of Deflation of Pneumatic Tourniquet on the Change of Optic Nerve Sheath Diameter in Patients Undergoing Knee Surgery

The purpose of this study is to evaluate the change of the optic nerve sheath diameter after deflation of pneumatic tourniquet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Deflation of pneumatic tourniquet could induces many changes in various organ systems. It has been shown to affect intracranial pressure. Thus, the investigators evaluate the change of optic nerve sheath diameter using ultrasound after deflation of pneumatic tourniquet in patients undergoing knee surgery.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing knee surgery using pneumatic tourniquet

Description

Inclusion Criteria:

  • ASA physical status 1-4
  • patients undergoing knee surgery using pneumatic tourniquet

Exclusion Criteria:

  • patients who refuse to participate in this study
  • patients with history of cerebrovascular disease
  • patients who are judged ineligible by the medical staff to participate in the study for other reasons

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of optic nerve sheath diameter
Time Frame: 5 minutes before deflation and at 5-minute intervals for 10 minutes after deflation
difference in optic nerve sheath diameter measured using ultrasound before and after deflation of pneumatic tourniquet
5 minutes before deflation and at 5-minute intervals for 10 minutes after deflation

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Won Uk Koh, M.D., Ph.D., Asan 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 (Actual)

November 15, 2018

Primary Completion (Actual)

December 13, 2018

Study Completion (Actual)

December 13, 2018

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1172 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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