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Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996813
First Posted: November 27, 2013
Last Update Posted: July 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Doug Evans, Loyola University
  Purpose

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 Intervention
Obesity Shoulder Impingement Device: Compression Hose

Study Type: Observational
Study Design: 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

Further study details as provided by Doug Evans, Loyola University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 23
Study Start Date: December 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:
Abstract from protocol listed above with hypothesis
  Eligibility

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.
Criteria

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
  Contacts and Locations
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


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

Publications:
Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
Ko SH, Cho YW, Park SH, Jeong JG, Shin SM, Kang G. Cerebral oxygenation monitoring of patients during arthroscopic shoulder surgery in the sitting position. Korean J Anesthesiol. 2012 Oct;63(4):297-301. doi: 10.4097/kjae.2012.63.4.297. Epub 2012 Oct 12.
Papadonikolakis A, Wiesler ER, Olympio MA, Poehling GG. Avoiding catastrophic complications of stroke and death related to shoulder surgery in the sitting position. Arthroscopy. 2008 Apr;24(4):481-2. doi: 10.1016/j.arthro.2008.02.005. Review.
Dippmann C, Winge S, Nielsen HB. Severe cerebral desaturation during shoulder arthroscopy in the beach-chair position. Arthroscopy. 2010 Sep;26(9 Suppl):S148-50. doi: 10.1016/j.arthro.2010.03.012.
Warrender WJ, Brown OL, Abboud JA. Outcomes of arthroscopic rotator cuff repairs in obese patients. J Shoulder Elbow Surg. 2011 Sep;20(6):961-7. doi: 10.1016/j.jse.2010.11.006. Epub 2011 Feb 15.
Salazar D, Sears BW, Andre J, Tonino P, Marra G. Cerebral desaturation during shoulder arthroscopy: a prospective observational study. Clin Orthop Relat Res. 2013 Dec;471(12):4027-34. doi: 10.1007/s11999-013-2987-6. Epub 2013 Apr 19.
Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15.

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 Submitted: November 22, 2013
First Posted: November 27, 2013
Results First Submitted: May 29, 2014
Results First Posted: July 2, 2014
Last Update Posted: July 2, 2014
Last Verified: May 2014

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


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