Total Shoulder Arthroplasty Near-infrared Spectroscopy (TSA NIRS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Ischemia
• Intervention / Treatment: Device: Casmed Fore-Sight Elite; Device: Non-invasive Cardiac Output Monitor (NICOM)

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Near-infrared spectroscopy; Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)	Device: Casmed Fore-Sight Elite; Device: Non-invasive Cardiac Output Monitor (NICOM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Output (CO)	Cardiac output of patients as measured in liters per minute	Day of surgery
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
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
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
End Tidal Carbon Dioxide (ETCO2)	a lower score is a better outcome.	Day of surgery
Intravenous Fluid Volume		Day of surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2014-003