Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair
Primary Purpose
Shoulder Arthoscopy, Beach Chair Position, Cerebral Desaturation Events
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thigh High Compression Stockings
Sponsored by

About this trial
This is an interventional prevention trial for Shoulder Arthoscopy
Eligibility Criteria
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
Sites / Locations
- Loyola University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental
Arm Description
Subjects received standard operating room dress including sequential compression devices.
Subjects wore thigh high compression stockings in addition to standard operating room dress including sequential compression devices.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03996668
Brief Title
Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
On the day of surgery, enrolled patients whom have signed consent for participation in the study will be randomized to receive thigh high compression stockings with SCDs or SCDs alone. The importance of the investigation, proposed methodology, and potential risks of participation will be addressed. In the pre-operative holding area, a cerebral oximeter (INVOS 5100C, Covidien) will be placed on the skull as directed by the manufacturer. The sensors will be placed on the skull bilaterally in order to assess perfusion in both hemispheres. Cerebral oximeter is a non-invasive, transcutaneous tool that can be used to measure cerebral tissue oxygenation. The tool uses nearinfrared spectroscopy to measure the percentage of hemoglobin saturated with oxygen in the microcirculation of tissue within approximately 2-3cm below the skin. The technology is approved by the FDA in the anesthesia setting to monitor cerebral oxygenation and is commonly used in cardiothoracic surgery and its use has been validated in the surgical setting.11 A baseline cerebral tissue oxygen saturation (rSO2) will be recorded. All patients will be anesthetized using a standardized protocol. Once anesthesia has been induced, thigh high compression stockings will be applied to the appropriate group followed by SCDs. All patients in the study will wear sequential compression devices on both legs for thrombosis prophylaxis regardless of randomization. The patient will then be raised into the beach chair position and secured in the normal fashion and the planned surgery will begin. Intraoperative rSO2 data will be continuously recorded throughout the case. The system will be set to alarm when the rSO2 decreases greater than 20% from baseline. These events will be recorded throughout the case as CDEs. To avoid cerebral vascular injury, these events will be treated with a protocol by anesthesia including ephedrine, phenylephrine, and the patient may be returned to the supine position if needed. When surgery is complete, patients will be recovered in the post-anesthesia care unit. The study will be conducted at three facilities within the Loyola system: the Loyola Ambulatory Surgery Center at Oakbrook (LASCO), the Ambulatory Surgery Center at Loyola (ASC), and at Gottlieb Memorial Hospital (GMH). Personnel will include the attending surgeon, orthopaedic surgery residents, and anesthesia staff assigned to each case, all of whom will be fully educated on the study and protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthoscopy, Beach Chair Position, Cerebral Desaturation Events, Obese
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients are not made aware of their study group or the presence of intraoperative cerebral desaturation events
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects received standard operating room dress including sequential compression devices.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects wore thigh high compression stockings in addition to standard operating room dress including sequential compression devices.
Intervention Type
Other
Intervention Name(s)
Thigh High Compression Stockings
Intervention Description
Thigh high compression stockings will be placed after induction of anesthesia and intubation.
Primary Outcome Measure Information:
Title
Cerebral Desaturation Events
Description
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
Time Frame
Intraoperative measurement that begins the with upright positioning and ends with return to supine positioning. There are no postoperative measures.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nickolas Garbis, 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
IPD will not be shared
Citations:
PubMed Identifier
16171668
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. doi: 10.1016/j.jclinane.2004.09.012.
Results Reference
background
PubMed Identifier
18375282
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.
Results Reference
background
PubMed Identifier
19490464
Citation
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.
Results Reference
background
PubMed Identifier
23415820
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.
Results Reference
background
PubMed Identifier
20511029
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.
Results Reference
background
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Effect of Compression Stockings on Cerebral Desaturation Events in Obese Patients Undergoing Shoulder Arthroscopy in the Beach Chair
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