Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

• Sponsor: Loyola University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01996813
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site Per Month: 0.8

Study Details

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	N/A

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

• Study Type: Interventional
• 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: Mar 28, 2013
• Actual Primary Completion Date: Jul 27, 2015
• Actual Study Completion Date: Jul 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 Names: 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

1. Cerebral Desaturation Event [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

1. Operation Time [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center	Maywood	Illinois	United States	60153

Sponsors and Collaborators

• Loyola University

Investigators

• Principal Investigator: Douglas Evans, MD, Loyola University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Hamdan A. Management of varicose veins and venous insufficiency. JAMA. 2012 Dec 26;308(24):2612-21. doi: 10.1001/jama.2012.111352.
• 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.
• 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.
• 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.
• 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.
• 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. doi: 10.1016/j.jclinane.2004.09.012.
• 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. doi: 10.1097/00000539-199602000-00010.
• 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. doi: 10.1002/j.1552-4604.1994.tb04977.x.

• Responsible Party: Doug Evans, MD, Loyola University
• ClinicalTrials.gov Identifier: NCT01996813
• Other Study ID Numbers: 205159
• First Posted: Nov 27, 2013
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, MD, Loyola University: arthroscopy; shoulder; obesity; beach chair; compression hose
• Additional relevant MeSH terms: Shoulder Impingement Syndrome

Study Results

Participant Flow

Recruitment Details	For the prospective case cohort, 23 participants were recruited from December 2013 through May 2014 (6 months) from a tertiary care practice. The remaining 24 participants were historical control participants

Arm/Group Title	Prospective Case	Historical Control
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	23	24
COMPLETED	23	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Historical Control	Prospective Case	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	24	23	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.33 (11.53)	52.96 (10.82)	53.15 (11.07)
Sex: Female, Male (Count of Participants)
Female	8 33.3%	12 52.2%	20 42.6%
Male	16 66.7%	11 47.8%	27 57.4%
Region of Enrollment (participants) [Number]
United States	24 100%	23 100%	47 100%
Body Mass Index (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	35.00	33.40	34.30
Comorbid Diabetes (Count of Participants)
No	19 79.2%	19 82.6%	38 80.9%
Yes	5 20.8%	4 17.4%	9 19.1%
Comorbid Peripheral Vascular Disease (Count of Participants)
No	24 100%	22 95.7%	46 97.9%
Yes	0 0%	1 4.3%	1 2.1%
Comorbid Hypertension (Count of Participants)
No	10 41.7%	10 43.5%	20 42.6%
Yes	14 58.3%	13 56.5%	27 57.4%
Comorbid Obstructive Sleep Apnea (Count of Participants)
No	16 66.7%	17 73.9%	33 70.2%
Yes	8 33.3%	6 26.1%	14 29.8%
Comorbid Coronary Artery Disease (Count of Participants)
No	21 87.5%	22 95.7%	43 91.5%
Yes	3 12.5%	1 4.3%	4 8.5%
Comorbid Chronic Obstructive Pulmonary Disease (Count of Participants)
No	22 91.7%	22 95.7%	44 93.6%
Yes	2 8.3%	1 4.3%	3 6.4%
Smoker (Count of Participants)
No	15 62.5%	21 91.3%	36 76.6%
Yes	9 37.5%	2 8.7%	11 23.4%
Technique used to secure the airway (Count of Participants)
Endotracheal Tube	3 12.5%	6 26.1%	9 19.1%
Laryngeal Mask Airway	21 87.5%	17 73.9%	38 80.9%

Outcome Measures

1. Primary Outcome

Title	Cerebral Desaturation Event
Description	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.
Time Frame	Assessed intraoperatively, an average of 114 minutes

Outcome Measure Data

Analysis Population Description

The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.

Arm/Group Title	Historical Control	Prospective Case
Arm/Group Description	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.	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.
Measure Participants	24	23
No Cerebral Desaturation Event	17 70.8%	22 95.7%
Cerebral desaturation event	7 29.2%	1 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control, Prospective Case
	Comments	The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.0553
	Comments	The exact p-value was estimated
	Method	Regression, Logistic
	Comments	The method was exact logistic regression
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.115
	Confidence Interval	(2-Sided) 95%; 0.002 to 1.034
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Operation Time
Description	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.
Time Frame	End of surgery

Outcome Measure Data

Analysis Population Description

The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.

Arm/Group Title	Historical Control	Prospective Case
Arm/Group Description	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.	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.
Measure Participants	24	23
Median (Standard Deviation) [Minutes]	94.08 (15.47)	134.40 (44.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Historical Control, Prospective Case
	Comments	The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 2 sided
	Comments	A Satterthwaite correction was used to adjust the degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	40.31
	Confidence Interval	(2-Sided) 95%; 20.22 to 60.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected from December 2013 through May 2014 (6 months)
Adverse Event Reporting Description	In the historical control group, there are no participants at-risk for adverse events or all-cause mortality because they were a retrospective sample that did not receive compression stockings.
Arm/Group Title	Historical Control		Prospective Case
Arm/Group Description	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.		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.
All Cause Mortality
	Historical Control		Prospective Case
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/23 (0%)
Serious Adverse Events
	Historical Control		Prospective Case
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Historical Control		Prospective Case
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/23 (0%)

Limitations/Caveats

There are no limitations or caveats to report

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.