Total Shoulder Arthroplasty Near-infrared Spectroscopy
TSA NIRS
The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.
1 other identifier
observational
34
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
January 17, 2023
CompletedJanuary 17, 2023
April 1, 2022
10 months
July 16, 2014
April 12, 2022
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Cardiac Output (CO)
Day of surgery
Cardiac Index (CI)
Day of surgery
Stroke Volume (SV)
Day of surgery
Mean Arterial Pressure (MAP)
Day of surgery
End Tidal Carbon Dioxide (ETCO2)
Day of surgery
- +1 more secondary outcomes
Study Arms (1)
Near-infrared spectroscopy
Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Interventions
Eligibility Criteria
Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery
You may qualify if:
- Patients 18-99 undergoing total shoulder arthroplasty
- Planned general anesthesia + brachial plexus nerve block
- Planned arterial catheter
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
Related 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.
PMID: 19388618BACKGROUNDYadeau 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.
PMID: 21857267BACKGROUNDYadeau 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.
PMID: 21866430BACKGROUNDKoh 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.
PMID: 23571083BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jacques Yadeau
- Organization
- Hospital for Special Surgery, Anesthesiology
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques T YaDeau, MD, PhD
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 23, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
October 1, 2015
Last Updated
January 17, 2023
Results First Posted
January 17, 2023
Record last verified: 2022-04