Skip to main content
Clinical Trials/NCT02198183
NCT02198183
Completed
Not Applicable

The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.

Hospital for Special Surgery, New York1 site in 1 country34 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Ischemia
Sponsor
Hospital for Special Surgery, New York
Enrollment
34
Locations
1
Primary Endpoint
Number of Cerebral Desaturation Events
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
October 2015
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

Number of Cerebral Desaturation Events

Time Frame: 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 Outcomes

  • Stroke Volume (SV)(Day of surgery)
  • Cardiac Output (CO)(Day of surgery)
  • Cardiac Index (CI)(Day of surgery)
  • End Tidal Carbon Dioxide (ETCO2)(Day of surgery)
  • Intravenous Fluid Volume(Day of surgery)
  • Mean Arterial Pressure (MAP)(Day of surgery)

Study Sites (1)

Loading locations...

Similar Trials