NCT01996813

Compression Stocking Use in Shoulder Arthroscopy in Beach Chair

Completed NA Results posted Last updated 31 August 2018

What this trial tests

NA trial testing Thigh-high compression stockings in Obesity in 23 participants. Completed in 27 July 2015.

Timeline

28 March 2013

Primary endpoint
27 July 2015

27 July 2015

Quick facts

Lead sponsor	Loyola University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	23
Start date	28 March 2013
Primary completion	27 July 2015
Estimated completion	27 July 2015
Sites	1 location across United States

Drugs / interventions tested

• Thigh-high compression stockings

Conditions studied

• Obesity — all drugs for Obesity →
• Shoulder Impingement — all drugs for Shoulder Impingement →

Sponsor

Loyola University

Who can join

18 and older, any sex, with Obesity or Shoulder Impingement. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cerebral Desaturation Event Primary · 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.

Group	Value	95% CI
Historical Control	17
Prospective Case	22
Historical Control	7
Prospective Case	1

Operation Time Secondary · 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.

Group	Value	95% CI
Historical Control	94.08	± 15.47
Prospective Case	134.40	± 44.44

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.