An interventional study of Thigh-high compression stockings in Obesity and Shoulder Impingement, sponsored by Loyola University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Loyola University · Not applicable, Interventional, and Prevention
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
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's enrollment of 23 is below the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
Browse Shoulder Impingement Syndrome studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Exclusion Criteria:
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
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.
The intervention in this study are thigh-high compression stockings manufactured by Covidien.
Also known as: Thrombo-Embolic Deterrent (TED) Anti-Embolism Stockings
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
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
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
| Milestone | Prospective Case | Historical Control |
|---|---|---|
| Started | 23 | 24 |
| Completed | 23 | 24 |
| Not completed | 0 | 0 |
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.
| Participants | Historical Control | Prospective Case |
|---|---|---|
| No Cerebral Desaturation Event | 17 | 22 |
| Cerebral desaturation event | 7 | 1 |
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.
| Minutes | Historical Control | Prospective Case |
|---|---|---|
| Operation Time | 94.08 ± 15.47 | 134.40 ± 44.44 |
Collected over Adverse event data were collected from December 2013 through May 2014 (6 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Historical Control | — | — | — |
| Prospective Case | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
The baseline 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.
| Age, Continuous(years) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| Mean | 53.33 ± 11.53 | 52.96 ± 10.82 | 53.15 ± 11.07 |
| Sex: Female, Male(Participants) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| Female | 8 | 12 | 20 |
| Male | 16 | 11 | 27 |
| Region of Enrollment(participants) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| United States | 24 | 23 | 47 |
| Body Mass Index(kg/m^2) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| Median | 35.00 (32.55 to 37.90) | 33.40 (31.20 to 36.10) | 34.30 (31.30 to 37.60) |
| Comorbid Diabetes(Participants) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| No | 19 | 19 | 38 |
| Yes | 5 | 4 | 9 |
| Comorbid Peripheral Vascular Disease(Participants) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| No | 24 | 22 | 46 |
| Yes | 0 | 1 | 1 |
| Comorbid Hypertension(Participants) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| No | 10 | 10 | 20 |
| Yes | 14 | 13 | 27 |
| Comorbid Obstructive Sleep Apnea(Participants) | Historical Control | Prospective Case | Total |
|---|---|---|---|
| No | 16 | 17 | 33 |
| Yes | 8 | 6 | 14 |
4 further baseline measures are reported on the registry.
Plan to share: No — There is no plan to make individual participant data available to other researchers
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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