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临床试验/NCT04736212
NCT04736212已完成不适用

Assessment of Breathing Using an Under-bed Weighing Scale

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年3月24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
16
试验地点
1
主要终点
Postoperative pulmonary complications

研究概览

简要总结

The aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, BSS) to predict postoperative pulmonary complications in high-risk surgical patients.

The study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.

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

  • Age 18 years or older
  • Undergoing non-cardiac surgery under general anesthesia.
  • Score ≥ 25 in the risk prediction score (Table1)

排除标准

  • Ambulatory (outpatient) surgery
  • Transfer directly to the ICU
  • Remain intubated/ planned to remain intubated after surgery
  • Pregnant patients: as detected by patient self-reporting of diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC.
  • Patients enrolled in other interventional studies which could confound the primary endpoint.

结局指标

主要结局

Postoperative pulmonary complications

时间窗: First 7 postoperative days

atelectasis, pneumonia, acute respiratory distress syndrome, pulmonary aspiration, re-intubation, unprecedented non-invasive ventilation, unplanned ICU admission, or re-admission to the hospital due to respiratory complication.

次要结局

  • Hospital length of stay(30 days after surgery)
  • Postoperative pulmonary complications(First 3 postoperative days)
  • Major adverse Cardiovascular events(First 7 postoperative days)
  • Adverse discharge disposition(30 days after surgery)

研究者

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

Maximilian S Schaefer

Assistant Professor of Anesthesia

Beth Israel Deaconess Medical Center

研究点 (1)

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