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Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

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ClinicalTrials.gov Identifier: NCT01996813
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : July 2, 2014
Last Update Posted : July 2, 2014
Information provided by (Responsible Party):
Doug Evans, Loyola University

Brief Summary:

Shoulder arthroscopy is one of the most commonly performed orthopaedic procedures and it is often done with the patient in the upright, or beach chair position (BCP).

There have been multiple reported complications associated with the BCP, including cerebral ischemia, loss of vision, ophthalmoplegia, stroke, and even death. It has been reported that patients with a body mass index (BMI) of 34 or greater are as much as 12 times more likely to experience cerebral desaturation events (CDEs) compared to non-obese patients. CDEs in the upright position are hypothesized to be partially related to reduced cardiac preload due to venous pooling in the lower extremities which is exaggerated in obese patients. This prospective observational study aims to determine if the use of compression stockings in obese patients undergoing shoulder arthroscopy in the BCP can reduce the incidence, frequency, or magnitude of CDEs experienced by the patient. We predict that compression hose will help to reduce cerebral desaturation events.

Condition or disease Intervention/treatment
Obesity Shoulder Impingement Device: Compression Hose

Detailed Description:
Abstract from protocol listed above with hypothesis

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair Position: an Observational Study
Study Start Date : December 2013
Primary Completion Date : May 2014
Study Completion Date : May 2014

Group/Cohort Intervention/treatment
Compression Hose
All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Device: Compression Hose
Intervention in this case is placement of compression hose on patients

Primary Outcome Measures :
  1. Incidence of Intraoperative Cerebral Desaturation Event [ Time Frame: will be assessed intraoperatively ]
    The primary outcome measure will be to determine if the application of compression hose on the legs of obese patients will have an impact on the incidence of cerebral desaturation events during shoulder arthroscopy in the beach chair position.

Secondary Outcome Measures :
  1. Length of Cerebral Desaturation Event [ Time Frame: will be assessed intraoperatively ]
    The length of time of each cerebral desaturation event (CDE) will be recorded for each occurrence.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient evaluated at our outpatient orthopaedic clinic at a major academic institution who has a BMI > 30 who will undergo shoulder arthroscopy in the beach chair position will be invited to participate in the study, provided they do not have any exclusion criteria listed below.

Inclusion Criteria:

  • All patients over age over 18 years old with a BMI > 30 undergoing shoulder arthroscopy in beach chair position

Exclusion Criteria:

  • age < 18
  • BMI < 30
  • >90% occlusion of carotid artery
  • history of stroke / transient ischemic attack / syncope
  • women who are pregnant

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): NCT01996813

United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Principal Investigator: Douglas Evans, MD Loyola University


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doug Evans, MD, Loyola University
ClinicalTrials.gov Identifier: NCT01996813     History of Changes
Other Study ID Numbers: LUMC-205159
First Posted: November 27, 2013    Key Record Dates
Results First Posted: July 2, 2014
Last Update Posted: July 2, 2014
Last Verified: May 2014

Keywords provided by Doug Evans, Loyola University:
beach chair
compression hose