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 : August 31, 2018

Sponsor:

Information provided by (Responsible Party):

Doug Evans, Loyola University

Study Description

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 controls. 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

Condition or disease	Intervention/treatment	Phase
Obesity Shoulder Impingement	Device: Thigh-high compression stockings	Not Applicable

Detailed Description:

There have been numerous studies recently in the orthopaedic surgery and anesthesia literature related to both complications associated with arthroscopy in the BCP and ongoing efforts to improve patient safety. Advantages of this position when compared with the lateral decubitus position include easier anatomic orientation, lack of traction on the brachial plexus, ease of exam under anesthesia, and easier conversion to an open approach if needed. While extremely uncommon, complications such as ischemic brain and spinal cord injury as well as visual loss and ophthalmoplegia have been reported. A recent study reported that obesity increases the likelihood of having a CDE by as many as 12 times. CDEs were defined as intra-operative decreases in regional cerebral tissue oxygen saturation (rSO2) of 20% or greater from baseline as measured by near-infrared spectroscopy (NIRS). Since obesity is so common, it was decided to investigate a measure to potentially help decrease CDEs in this population.

The exact etiology of CDEs has not been definitively demonstrated and it is felt to be multifactorial. The sympathetic nervous system normally increases systemic vascular resistance and heart rate to maintain mean arterial blood pressure (MAP) when a person sits up or stands upright. This response is blunted by the vasodilatory effects of intravenous and inhaled anesthetics used in patients undergoing shoulder arthroscopy in the BCP. The result is decreased MAP and cerebral perfusion pressure that can contribute to hypoxic brain injury. The use of sequential compression devices placed on the legs of patients undergoing shoulder arthroscopy in the BCP has been shown to reduce the incidence of hypotension by increasing cardiac preload. This study excluded obese patients (BMI > 30) and did not directly monitor rSO2, but rather only monitored hemodynamic variables.

Compression stockings are often used in patients with venous insufficiency to help with pain and to control edema. The stockings compress the soft tissues and veins, and in conjunction with sequential compression devices (SCDs), may help to increase preload in an anesthetized patient in the BCP. To our knowledge, the effect of compression stockings on cerebral perfusion has not been studied. This study aims to determine if the use of compression stockings in obese patients undergoing shoulder arthroscopy in the BCP can decrease the incidence, frequency or magnitude of CDEs as measured by NIRS. We hypothesize that the use of compression stockings will result in decreased incidence and frequency of CDEs in our population.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	23 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair Position
Actual Study Start Date :	March 28, 2013
Actual Primary Completion Date :	July 27, 2015
Actual Study Completion Date :	July 27, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Prospective Case Patients with a BMI of 30 kg/m^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.	Device: Thigh-high compression stockings The intervention in this study are thigh-high compression stockings manufactured by Covidien. Other Name: Thrombo-Embolic Deterrent (TED) Anti-Embolism Stockings
No Intervention: Historical Control Patients with a BMI of 30 kg/m^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.

Outcome Measures

Primary Outcome Measures :

Cerebral Desaturation Event [ Time Frame: Assessed intraoperatively, an average of 114 minutes ]
The prevalence of a cerebral desaturation event is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.

Secondary Outcome Measures :

Operation Time [ Time Frame: End of surgery ]
The length of operation time (in minutes) is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years or older
BMI greater than or equal to 30 kg/m^2
Capable of receiving an interscalene nerve block.

Exclusion Criteria:

Age < 18
History of carotid artery stenosis equal to or greater than 90%
History of stroke
History of transient ischemic attack
History of syncope
History of vision loss

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

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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153

Sponsors and Collaborators

Loyola University

Investigators

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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.

Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9.

Bhatti MT, Enneking FK. Visual loss and ophthalmoplegia after shoulder surgery. Anesth Analg. 2003 Mar;96(3):899-902. doi: 10.1213/01.ANE.0000047272.31849.F9.

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.

Fischer GW, Torrillo TM, Weiner MM, Rosenblatt MA. The use of cerebral oximetry as a monitor of the adequacy of cerebral perfusion in a patient undergoing shoulder surgery in the beach chair position. Pain Pract. 2009 Jul-Aug;9(4):304-7. doi: 10.1111/j.1533-2500.2009.00282.x. Epub 2009 Mar 17.

Peruto CM, Ciccotti MG, Cohen SB. Shoulder arthroscopy positioning: lateral decubitus versus beach chair. Arthroscopy. 2009 Aug;25(8):891-6. doi: 10.1016/j.arthro.2008.10.003. Epub 2008 Nov 28. Review.

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.

Smith JJ, Porth CM, Erickson M. Hemodynamic response to the upright posture. J Clin Pharmacol. 1994 May;34(5):375-86. Review.

Kwak HJ, Lee JS, Lee DC, Kim HS, Kim JY. The effect of a sequential compression device on hemodynamics in arthroscopic shoulder surgery using beach-chair position. Arthroscopy. 2010 Jun;26(6):729-33. doi: 10.1016/j.arthro.2009.10.001. Epub 2010 Mar 3.

Hamdan A. Management of varicose veins and venous insufficiency. JAMA. 2012 Dec 26;308(24):2612-21. doi: 10.1001/jama.2012.111352. Review.

Pollard V, Prough DS, DeMelo AE, Deyo DJ, Uchida T, Stoddart HF. Validation in volunteers of a near-infrared spectroscope for monitoring brain oxygenation in vivo. Anesth Analg. 1996 Feb;82(2):269-77.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tauchen AJ, Salazar D, Barton GJ, Francois A, Tonino P, Garbis NG, Evans D. The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach-Chair Position. Arthroscopy. 2015 Dec;31(12):2352-64. doi: 10.1016/j.arthro.2015.06.017. Epub 2015 Aug 3.

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Responsible Party:	Doug Evans, MD, Loyola University
ClinicalTrials.gov Identifier:	NCT01996813
Other Study ID Numbers:	205159
First Posted:	November 27, 2013 Key Record Dates
Results First Posted:	July 2, 2014
Last Update Posted:	August 31, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	There is no plan to make individual participant data available to other researchers

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Doug Evans, Loyola University:


arthroscopy shoulder obesity beach chair compression hose

Additional relevant MeSH terms:

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Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

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