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Total Shoulder Arthroplasty Near-infrared Spectroscopy (TSA NIRS)

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Completed

Conditions

Cerebral Ischemia

Treatments

Device: Non-invasive Cardiac Output Monitor (NICOM)
Device: Casmed Fore-Sight Elite

Study type

Observational

Funder types

Other

Identifiers

NCT02198183
2014-003

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

34 participants in 1 patient group

Near-infrared spectroscopy
Description:
Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
Treatment:
Device: Non-invasive Cardiac Output Monitor (NICOM)
Device: Casmed Fore-Sight Elite

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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