Total Shoulder Arthroplasty Near-infrared Spectroscopy
- Conditions
- Cerebral Ischemia
- Interventions
- Device: Casmed Fore-Sight EliteDevice: Non-invasive Cardiac Output Monitor (NICOM)
- Registration Number
- NCT02198183
- Lead Sponsor
- Hospital for Special Surgery, New York
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- Patients 18-99 undergoing total shoulder arthroplasty
- Planned general anesthesia + brachial plexus nerve block
- Planned arterial catheter
-
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Near-infrared spectroscopy Casmed Fore-Sight Elite Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Near-infrared spectroscopy Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
- Primary Outcome Measures
Name Time Method Number of Cerebral Desaturation Events Day of surgery 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.
- Secondary Outcome Measures
Name Time Method Intravenous Fluid Volume Day of surgery Stroke Volume (SV) Day of surgery Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.
Cardiac Output (CO) Day of surgery Cardiac output of patients as measured in liters per minute
Cardiac Index (CI) Day of surgery 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.
End Tidal Carbon Dioxide (ETCO2) Day of surgery a lower score is a better outcome.
Mean Arterial Pressure (MAP) Day of surgery mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States