Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2019
Source Loyola University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Thigh High Compression Stockings
Thigh high compression stockings will be placed after induction of anesthesia and intubation.

Locations

Country Name City State
United States Loyola University Medical Center Maywood Illinois

Sponsors (1)

Lead Sponsor Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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.
See also
  Status Clinical Trial Phase
Completed NCT04105075 - COPD in Obese Patients
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Recruiting NCT05857150 - Exercise Response in Humans With Obesity
Completed NCT03532672 - Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT02618486 - The Effects of Obesity on Non Surgical Periodontal Therapy N/A
Completed NCT01724515 - PGC-1 and Mitochondrial Dysfunction in Diabetes N/A
Completed NCT01724502 - Mitochondrial Dysfunction in Diabetes N/A
Active, not recruiting NCT01634204 - Efficacy of a Web-based Weight Loss Program Phase 2
Completed NCT01421589 - Growth Hormone Treatment on Phosphocreatine Recovery in Obesity N/A
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT03528304 - Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss N/A
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01726647 - Metabolism Associated With Abdominal Fat Mass Distribution N/A
Active, not recruiting NCT02125149 - The Expecting Study N/A
Completed NCT05737927 - Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects Phase 1
Completed NCT05433506 - Safety and Pharmacokinetics of HU6 Phase 1
Completed NCT02871882 - Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus Phase 2
Completed NCT03298464 - Study of NGM313 in Obese Participants Phase 1
Completed NCT05061173 - Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults N/A