Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Doug Evans, Loyola University
ClinicalTrials.gov Identifier:
NCT01996813
First received: November 22, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 patients. 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. We predict that compression hose will help to reduce cerebral desaturation events.


Condition Intervention
Obesity
Shoulder Impingement
Device: Compression Hose

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair Position: an Observational Study

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Incidence of Intraoperative Cerebral Desaturation Event [ Time Frame: will be assessed intraoperatively ] [ Designated as safety issue: Yes ]
    The primary outcome measure will be to determine if the application of compression hose on the legs of obese patients will have an impact on the incidence of cerebral desaturation events during shoulder arthroscopy in the beach chair position.


Secondary Outcome Measures:
  • Length of Cerebral Desaturation Event [ Time Frame: will be assessed intraoperatively ] [ Designated as safety issue: Yes ]
    The length of time of each cerebral desaturation event (CDE) will be recorded for each occurrence.


Enrollment: 23
Study Start Date: December 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Compression Hose
All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.
Device: Compression Hose
Intervention in this case is placement of compression hose on patients

Detailed Description:

Abstract from protocol listed above with hypothesis

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient evaluated at our outpatient orthopaedic clinic at a major academic institution who has a BMI > 30 who will undergo shoulder arthroscopy in the beach chair position will be invited to participate in the study, provided they do not have any exclusion criteria listed below.

Criteria

Inclusion Criteria:

  • All patients over age over 18 years old with a BMI > 30 undergoing shoulder arthroscopy in beach chair position

Exclusion Criteria:

  • age < 18
  • BMI < 30
  • >90% occlusion of carotid artery
  • history of stroke / transient ischemic attack / syncope
  • women who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996813

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Douglas Evans, MD Loyola University
  More Information

Publications:

Responsible Party: Doug Evans, MD, Loyola University
ClinicalTrials.gov Identifier: NCT01996813     History of Changes
Other Study ID Numbers: LUMC-205159
Study First Received: November 22, 2013
Results First Received: May 29, 2014
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
arthroscopy
shoulder
obesity
beach chair
compression hose

Additional relevant MeSH terms:
Obesity
Shoulder Impingement Syndrome
Body Weight
Joint Diseases
Musculoskeletal Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014