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临床试验/NCT01933841
NCT01933841已完成不适用

The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
1
主要终点
Decrease in incidence of postoperative residual curarization

研究概览

简要总结

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be introducing monitoring as part of standard of care. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.

Our study is designed to test the following hypotheses:

Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at VUMC.

Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the incidence of short- and long-term postoperative complications at VUMC.

详细描述

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. Physiological data suggest that PORC impairs normal respiratory function, and compelling evidence suggests PORC impairs clinical recovery in the immediate postoperative period and prolongs PACU length of stay. However, despite the widespread use of NMBDs and the frequent occurrence of PORC, limitations in the literature prevent an understanding of their full impact on clinical outcomes. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.

The incidence of PORC and postoperative complications after the introduction of monitoring in the PACU will be determined by measuring TOF ratios and tracking the postoperative outcomes in the surgical patients over time.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Surgical patients > 18 years of age
  • Received one or more NMBDs during surgery
  • Surgery took place during the first 120 days following the introduction of TOF monitoring in the PACU

排除标准

  • Surgical patients < 18 years of age
  • Received no NMBDs during surgery
  • Transfer from the OR to the PACU was delayed (by high PACU volume, for example)
  • Had a procedure or has a preexisting condition that prevents accurate monitoring

结局指标

主要结局

Decrease in incidence of postoperative residual curarization

时间窗: 10 minute after arrival to PACU

This aim will test the hypothesis that initiation of quantitative Train-Of-Four monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at Vanderbilt University Medical Center. Quantitative TOF monitoring will be introduced as a standard component of the PACU entry evaluation for all patients that receive NMBDs as part of their care. It is expected that the proportion of patients with TOF \< 0.9 will decrease over time after initiation of the routine monitoring system.

次要结局

  • Decrease in need for reintubation(24 hours after PACU entry)
  • Decrease in incidence of perioperative pneumonia(28 days post-operatively)
  • Decrease in time to readiness for discharge(Hospital stay (Expected average of 3 days))
  • Decrease in length of stay in the PACU(PACU stay (Typically 1-2 hours post-operatively))
  • Decrease in the incidence of hemoglobin desaturation(PACU stay (Typically 1-2 hours post-operatively))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward Sherwood

Professor

Vanderbilt University Medical Center

研究点 (1)

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