Total Shoulder Arthroplasty Near-infrared Spectroscopy (TSA NIRS)
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|ClinicalTrials.gov Identifier: NCT02198183|
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : June 18, 2018
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.
|Condition or disease||Intervention/treatment|
|Cerebral Ischemia||Device: Casmed Fore-Sight Elite Device: Non-invasive Cardiac Output Monitor (NICOM)|
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||October 2015|
Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Device: Casmed Fore-Sight Elite
Device: Non-invasive Cardiac Output Monitor (NICOM)
- Cerebral Desaturation Events [ Time Frame: On day of surgery ]The primary outcome is defined as cerebral desaturation events (CDE) by >20% from baseline that lasts for 90 seconds or longer.
- Cardiac Output (CO) [ Time Frame: Day of surgery ]
- Cardiac Index (CI) [ Time Frame: Day of surgery ]
- Stroke Volume (SV) [ Time Frame: Day of surgery ]
- Mean Arterial Pressure (MAP) [ Time Frame: Day of surgery ]
- Fraction of inspired oxygen (FIO2) [ Time Frame: Day of surgery ]
- End Tidal Carbon Dioxide (ETCO2) [ Time Frame: Day of surgery ]
- Intravenous fluid volume [ Time Frame: Day of surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198183
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jacques T YaDeau, MD, PhD||Hospital for Special Surgery, New York|