N/A N=34

Total Shoulder Arthroplasty Near-infrared Spectroscopy

Cerebral Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT02198183 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Number of Cerebral Desaturation Events — 0 Number of CDE Incidences

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Casmed Fore-Sight Elite (Device); Non-invasive Cardiac Output Monitor (NICOM) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Cerebral Desaturation Events	—	—
SECONDARY Cardiac Output (CO)	5.6	—
SECONDARY Cardiac Index (CI)	3	—
SECONDARY Stroke Volume (SV)	74	—
SECONDARY Mean Arterial Pressure (MAP)	76; 67	—
SECONDARY End Tidal Carbon Dioxide (ETCO2)	44; 45	—
SECONDARY Intravenous Fluid Volume	1408	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02198183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.