跳至主要内容
临床试验/NCT02198183
NCT02198183已完成不适用

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

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Number of Cerebral Desaturation Events

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18-99 undergoing total shoulder arthroplasty
  • Planned general anesthesia + brachial plexus nerve block
  • Planned arterial catheter

排除标准

  • 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
  • infection at block site
  • pre-existing neurological injury to operative limb
  • Non-English speaking patients

结局指标

主要结局

Number of Cerebral Desaturation Events

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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