MedPath

Total Shoulder Arthroplasty Near-infrared Spectroscopy

Completed
Conditions
Cerebral Ischemia
Interventions
Device: Casmed Fore-Sight Elite
Device: 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
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Near-infrared spectroscopyCasmed Fore-Sight EliteCasmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Near-infrared spectroscopyNon-invasive Cardiac Output Monitor (NICOM)Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Primary Outcome Measures
NameTimeMethod
Number of Cerebral Desaturation EventsDay 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
NameTimeMethod
Intravenous Fluid VolumeDay 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

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