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Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair Position

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01996813
Enrollment
23
Registered
2013-11-27
Start date
2013-03-28
Completion date
2015-07-27
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Shoulder Impingement

Keywords

arthroscopy, shoulder, obesity, beach chair, compression hose

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

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.

Interventions

DEVICEThigh-high compression stockings

The intervention in this study are thigh-high compression stockings manufactured by Covidien.

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Desaturation EventAssessed intraoperatively, an average of 114 minutesThe 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

MeasureTime frameDescription
Operation TimeEnd of surgeryThe 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.

Countries

United States

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

Participants by arm

ArmCount
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.
24
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.
23
Total47

Baseline characteristics

CharacteristicHistorical ControlProspective CaseTotal
Age, Continuous53.33 years
STANDARD_DEVIATION 11.53
52.96 years
STANDARD_DEVIATION 10.82
53.15 years
STANDARD_DEVIATION 11.07
Body Mass Index35.00 kg/m^233.40 kg/m^234.30 kg/m^2
Comorbid Chronic Obstructive Pulmonary Disease
No
22 Participants22 Participants44 Participants
Comorbid Chronic Obstructive Pulmonary Disease
Yes
2 Participants1 Participants3 Participants
Comorbid Coronary Artery Disease
No
21 Participants22 Participants43 Participants
Comorbid Coronary Artery Disease
Yes
3 Participants1 Participants4 Participants
Comorbid Diabetes
No
19 Participants19 Participants38 Participants
Comorbid Diabetes
Yes
5 Participants4 Participants9 Participants
Comorbid Hypertension
No
10 Participants10 Participants20 Participants
Comorbid Hypertension
Yes
14 Participants13 Participants27 Participants
Comorbid Obstructive Sleep Apnea
No
16 Participants17 Participants33 Participants
Comorbid Obstructive Sleep Apnea
Yes
8 Participants6 Participants14 Participants
Comorbid Peripheral Vascular Disease
No
24 Participants22 Participants46 Participants
Comorbid Peripheral Vascular Disease
Yes
0 Participants1 Participants1 Participants
Region of Enrollment
United States
24 participants23 participants47 participants
Sex: Female, Male
Female
8 Participants12 Participants20 Participants
Sex: Female, Male
Male
16 Participants11 Participants27 Participants
Smoker
No
15 Participants21 Participants36 Participants
Smoker
Yes
9 Participants2 Participants11 Participants
Technique used to secure the airway
Endotracheal Tube
3 Participants6 Participants9 Participants
Technique used to secure the airway
Laryngeal Mask Airway
21 Participants17 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 23
other
Total, other adverse events
0 / 00 / 23
serious
Total, serious adverse events
0 / 00 / 23

Outcome results

Primary

Cerebral Desaturation Event

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

Population: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Historical ControlCerebral Desaturation EventNo Cerebral Desaturation Event17 Participants
Historical ControlCerebral Desaturation EventCerebral desaturation event7 Participants
Prospective CaseCerebral Desaturation EventNo Cerebral Desaturation Event22 Participants
Prospective CaseCerebral Desaturation EventCerebral desaturation event1 Participants
Comparison: 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 positionp-value: 0.055395% CI: [0.002, 1.034]Regression, Logistic
Secondary

Operation Time

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

Population: 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.

ArmMeasureValue (MEDIAN)Dispersion
Historical ControlOperation Time94.08 MinutesStandard Deviation 15.47
Prospective CaseOperation Time134.40 MinutesStandard Deviation 44.44
Comparison: 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 positionp-value: <0.00195% CI: [20.22, 60.39]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026