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临床试验/NCT03585400
NCT03585400已完成不适用

Validation of the REPS Prediction Tool to Improve Quality of Perioperative Care

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 101,510 人开始时间: 2018年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101,510
试验地点
1
主要终点
Postoperative Respiratory Complications (PRC)

研究概览

简要总结

Neuromuscular blocking agents' (NMBA) use during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Residual neuromuscular block (rNMB) after surgery is difficult to identify. We have recently developed the REsidual neuromuscular block Prediction Score (REPS), that predicts the risk for postoperative rNMB. Our primary objective is now to assess the predictive ability of the REPS for respiratory complications within seven days following general anaesthesia. The secondary objective is to compare the predictive values of REPS and train-of-four (TOF)-ratio below 0.90 for respiratory complications.

详细描述

Residual neuromuscular blockade occurs in about 20-60% of patients and depends on compound and dose of NMBA reversal agent used. While on the one hand, NMBAs optimize surgical conditions and facilitate mechanical ventilation in patients with ventilator asynchrony, on the other hand, these agents have been associated with respiratory complications and increased risk of readmission after ambulatory surgery. A consensus in regard to guidelines and thresholds to define the optimal strategy to optimize surgical conditions is yet to be achieved. We have shown that utilization of non-depolarizing muscle relaxants and their reversal agents can be improved by dedicated quality improvement techniques. We have also recently developed the REPS, a tool that predicts postoperative rNMB.

This is a retrospective, observational, cohort study based on on-file hospital data from Beth Israel Deaconess Medical Center, Boston, Massachusetts.

The primary aim is to validate the dichotomized REPS (high-risk versus low-risk for rNMB which corresponds to a REPS >4 and <4, respectively) for the outcome of postoperative respiratory complications with BIDMC data. The investigators will utilize the pre-defined variables identified to predict residual neuromuscular blockade (REPS) at BIDMC.

The secondary aim is to compare the predictive values of the dichotomized REPS with dichotomized train-of-four (TOF)-ratio (low TOF-ratio versus high TOF ratio which corresponds to a TOF-ratio <0.9 and >=0.9, respectively) for respiratory complications.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • 18 years or older
  • Non-cardiac surgery
  • General anesthesia with intermediate-acting NMBAs (atracurium, cisatracurium, vecuronium, or rocuronium)
  • Extubated in the operating room
  • PACU after surgery

排除标准

  • American Society of Anesthesiology (ASA) Physical Status Classification of 5 or 6
  • Did not receive neuromuscular blocking agents
  • Missing last covariates

结局指标

主要结局

Postoperative Respiratory Complications (PRC)

时间窗: After extubation, up to 7 days after surgery

PRC composite of invasive mechanical ventilation requirement within 7 postoperative days or immediate post-extubation desaturation (SpO2 \<90%) within 10 minutes.

次要结局

未报告次要终点

研究者

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

Matthias Eikermann

Professor of Anaesthesia

Beth Israel Deaconess Medical Center

研究点 (1)

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