NCT03782077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

28 days

First QC Date

December 19, 2018

Last Update Submit

December 19, 2018

Conditions

Intracranial Pressure Increase

Outcome Measures

Primary Outcomes (1)

  • change of optic nerve sheath diameter

    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

Interventions

Deflation of pneumatic tourniquetPROCEDURE

Deflation of pneumatic tourniquet

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing knee surgery using pneumatic tourniquet

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Kim HJ, Kim YJ, Kim J, Kim H, Ro YJ, Koh WU. Change in the optic nerve sheath diameter after deflation of a pneumatic tourniquet: a prospective observational study. Sci Rep. 2022 Jan 11;12(1):521. doi: 10.1038/s41598-021-04457-4.

    PMID: 35017581DERIVED

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Won Uk Koh, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 20, 2018

Study Start

November 15, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Locations

KR(1)