Cerebral Ischemia
Conditions
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.
Interventions
DEVICECasmed Fore-Sight Elite
DEVICENon-invasive Cardiac Output Monitor (NICOM)
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| End Tidal Carbon Dioxide (ETCO2) | Day of surgery | a lower score is a better outcome. |
| Intravenous Fluid Volume | Day of surgery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Near-infrared Spectroscopy Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Casmed Fore-Sight Elite
Non-invasive Cardiac Output Monitor (NICOM) | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Near-infrared Spectroscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: Day of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Near-infrared Spectroscopy | Number of Cerebral Desaturation Events | 0 Number of CDE Incidences |
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.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Near-infrared Spectroscopy | Cardiac Index (CI) | 3 L/min/m^2 | Standard Deviation 0.5 |
Secondary
Cardiac Output (CO)
Cardiac output of patients as measured in liters per minute
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Near-infrared Spectroscopy | Cardiac Output (CO) | 5.6 liters per minute | Standard Deviation 1.2 |
Secondary
End Tidal Carbon Dioxide (ETCO2)
a lower score is a better outcome.
Time frame: Day of surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Near-infrared Spectroscopy | End Tidal Carbon Dioxide (ETCO2) | GA without PPV | 44 mmHg | Standard Deviation 5 |
| Near-infrared Spectroscopy | End Tidal Carbon Dioxide (ETCO2) | GA with PPV | 45 mmHg | Standard Deviation 6 |
Secondary
Intravenous Fluid Volume
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Near-infrared Spectroscopy | Intravenous Fluid Volume | 1408 mL | Standard Deviation 227 |
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.
Time frame: Day of surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Near-infrared Spectroscopy | Mean Arterial Pressure (MAP) | GA without PPV | 76 percent | Standard Deviation 15 |
| Near-infrared Spectroscopy | Mean Arterial Pressure (MAP) | GA with PPV | 67 percent | Standard Deviation 17 |
Secondary
Stroke Volume (SV)
Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Near-infrared Spectroscopy | Stroke Volume (SV) | 74 milliliters | Standard Deviation 11 |