NCT03996668

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

June 11, 2019

Last Update Submit

June 21, 2019

Conditions

Shoulder ArthoscopyBeach Chair PositionCerebral Desaturation EventsObese

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Control

NO INTERVENTION

Subjects received standard operating room dress including sequential compression devices.

Experimental

EXPERIMENTAL

Subjects wore thigh high compression stockings in addition to standard operating room dress including sequential compression devices.

Other: Thigh High Compression Stockings

Interventions

Thigh High Compression StockingsOTHER

Thigh high compression stockings will be placed after induction of anesthesia and intubation.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patient over age 18
  • BMI \> 30
  • Undergoing shoulder arthroscopy in beach chair position

You may not qualify if:

  • Age \< 18 years
  • BMI \< 30
  • Known and documented \>90% occlusion of carotid artery
  • Prior neck surgery
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (5)

  • 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. doi: 10.1016/j.jclinane.2004.09.012.

    PMID: 16171668BACKGROUND

  • 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.

    PMID: 18375282BACKGROUND

  • 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.

    PMID: 19490464BACKGROUND

  • 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.

    PMID: 23415820BACKGROUND

  • 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.

    PMID: 20511029BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nickolas Garbis, MD

    Loyola University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients are not made aware of their study group or the presence of intraoperative cerebral desaturation events
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 25, 2019

Study Start

July 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

US(1)