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Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

Primary Purpose

Obesity, Shoulder Impingement

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thigh-high compression stockings
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring arthroscopy, shoulder, obesity, beach chair, compression hose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective Case

Historical Control

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 22, 2013
Last Updated
August 2, 2018
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT01996813
Brief Title
Compression Stocking Use in Shoulder Arthroscopy in Beach Chair
Official Title
The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair Position
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 28, 2013 (Actual)
Primary Completion Date
July 27, 2015 (Actual)
Study Completion Date
July 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Shoulder Impingement
Keywords
arthroscopy, shoulder, obesity, beach chair, compression hose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Case
Arm Type
Experimental
Arm 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.
Arm Title
Historical Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Thigh-high compression stockings
Other Intervention Name(s)
Thrombo-Embolic Deterrent (TED) Anti-Embolism Stockings
Intervention Description
The intervention in this study are thigh-high compression stockings manufactured by Covidien.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Evans, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers
Citations:
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20508134
Citation
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Citation
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Results Reference
derived

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Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

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