Obese Clinical Trial
Official title:
The Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair Position - A Randomized Prospective Study
NCT number | NCT03996668 |
Other study ID # | 209868 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | March 1, 2019 |
Verified date | June 2019 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study compares the effect of thigh high compression stockings on cerebral desaturation events in patients undergoing shoulder arthroscopy in the beach chair position with a BMI greater than or equal to 30.
Status | Completed |
Enrollment | 66 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - • All patient over age 18 - BMI > 30 - Undergoing shoulder arthroscopy in beach chair position Exclusion Criteria: - • Age < 18 years - BMI < 30 - Known and documented >90% occlusion of carotid artery - Prior neck surgery - Women who are pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Loyola University Medical Center | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University |
United States,
Fischer GW, Torrillo TM, Weiner MM, Rosenblatt MA. The use of cerebral oximetry as a monitor of the adequacy of cerebral perfusion in a patient undergoing shoulder surgery in the beach chair position. Pain Pract. 2009 Jul-Aug;9(4):304-7. doi: 10.1111/j.1533-2500.2009.00282.x. Epub 2009 Mar 17. — View Citation
Kwak HJ, Lee JS, Lee DC, Kim HS, Kim JY. The effect of a sequential compression device on hemodynamics in arthroscopic shoulder surgery using beach-chair position. Arthroscopy. 2010 Jun;26(6):729-33. doi: 10.1016/j.arthro.2009.10.001. Epub 2010 Mar 3. — View Citation
Papadonikolakis A, Wiesler ER, Olympio MA, Poehling GG. Avoiding catastrophic complications of stroke and death related to shoulder surgery in the sitting position. Arthroscopy. 2008 Apr;24(4):481-2. doi: 10.1016/j.arthro.2008.02.005. Review. — View Citation
Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. — View Citation
Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral Desaturation Events | Intraoperative Cerebral desaturation events is defined as a decrease of 20% or more in cerebral oxygenation percentage from a preoperative supine baseline and is measured by Near Infrared Spectroscopy | Intraoperative measurement that begins the with upright positioning and ends with return to supine positioning. There are no postoperative measures. |
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