Clinical trial NCT02198183: Total Shoulder Arthroplasty Near-infrared Spectroscopy
Official title: The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Ischemia
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Cerebral Desaturation Events
timeFrame: Day of surgery
Secondary outcomes:
measure: Cardiac Output (CO)
timeFrame: Day of surgery
measure: Cardiac Index (CI)
timeFrame: Day of surgery
measure: Stroke Volume (SV)
timeFrame: Day of surgery
measure: Mean Arterial Pressure (MAP)
timeFrame: Day of surgery
measure: End Tidal Carbon Dioxide (ETCO2)
timeFrame: Day of surgery
measure: Intravenous Fluid Volume
timeFrame: Day of surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058.
citation: Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e.
citation: Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
citation: Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6.