Total Shoulder Arthroplasty Near-infrared Spectroscopy

Cerebral Ischemia Clinical Trial

— TSA NIRS  

Official title:

The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198183
• Other study ID #: 2014-003
• Status: Completed
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV).

We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is well maintained under GA in the sitting position when epinephrine is used, but that decreased cardiac output increases the risk of cerebral desaturation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18-99 undergoing total shoulder arthroplasty

• Planned general anesthesia + brachial plexus nerve block

• Planned arterial catheter

Exclusion Criteria:

• Patients younger than 18 years older and older than 99

• Patients not intending to receive general anesthesia and peripheral nerve block

• Indication for endotracheal tube

• BMI = 30

• Ejection Fraction (if known) < 50%

• Known significant restrictive or obstructive pulmonary disease

• Patients with a history of transient ischemic attack (TIA) or stroke

• Patients with recent signs or symptoms of myocardial ischemia

• Current stress test positive for ischemia

• Intolerance to study medications

• pre-existing contraindication to regional anesthesia

• infection at block site

• pre-existing neurological injury to operative limb

• Non-English speaking patients

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Ischemia

Intervention

Device:
• Casmed Fore-Sight Elite

• Non-invasive Cardiac Output Monitor (NICOM)

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (4)

Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058. — View Citation

Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6. — View Citation

Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e. — View Citation

Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cerebral Desaturation Events	The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of >20% from baseline that lasts for 90 seconds or longer.	Day of surgery
Secondary	Cardiac Output (CO)	Cardiac output of patients as measured in liters per minute	Day of surgery
Secondary	Cardiac Index (CI)	Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.	Day of surgery
Secondary	Stroke Volume (SV)	Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.	Day of surgery
Secondary	Mean Arterial Pressure (MAP)	mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.	Day of surgery
Secondary	End Tidal Carbon Dioxide (ETCO2)	a lower score is a better outcome.	Day of surgery
Secondary	Intravenous Fluid Volume		Day of surgery