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Change of Optic Nerve Sheath Diameter After Deflation of Pneumatic Tourniquet

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ClinicalTrials.gov Identifier: NCT03782077
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hajung Kim, Asan Medical Center

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

Condition or disease Intervention/treatment
Intracranial Pressure Increase Procedure: Deflation of pneumatic tourniquet

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Deflation of Pneumatic Tourniquet on the Change of Optic Nerve Sheath Diameter in Patients Undergoing Knee Surgery
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Deflation of pneumatic tourniquet
    Deflation of pneumatic tourniquet


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients undergoing knee surgery using pneumatic tourniquet
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782077


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Won Uk Koh, M.D., Ph.D. Asan Medical Center

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Responsible Party: Hajung Kim, Clinical instructor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03782077     History of Changes
Other Study ID Numbers: 2018-1172
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases