跳至主要内容
临床试验/NCT07084363
NCT07084363招募中不适用

Quantitative Versus qUAlitative NeuromoniToring of neUroMuscular Block for Non-cardiothoracic Surgery (The QUANTUM Trial): Single-center Cluster Randomized Multiple Crossover Trial

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 1,032 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,032
试验地点
2
主要终点
lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes)

研究概览

简要总结

The purpose of this study is to assess the effect of quantitative block monitoring versus less expensive qualitative monitoring treatment effects on the lowest SpO2/FiO2 ratio in the PACU. The results will be incorporated into an enhanced recovery pathway for surgical patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

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

  • Patient age ≥ 18 years old;
  • General anesthesia with endotracheal intubation;
  • Neuromuscular block with rocuronium.

排除标准

  • Intubation before induction of anesthesia;
  • Critically ill patients admitted from the ICU;
  • Emergency cases;
  • Non-intubated patients;
  • Patients who will not be paralyzed through the surgery (spine).
  • Patients with an implanted electronic device (e.g. cardiac pacemaker)
  • Patients with allergies to adhesive
  • Patients with pre-existing neuromuscular disease (e.g. Myasthenia Gravis)

结局指标

主要结局

lowest SpO2/FiO2 ratio in the PACU (constant for at least 10 minutes)

时间窗: During the time in PACU (about 30 minutes to 6 hours)

次要结局

  • Collapsed composite (any vs none) of postoperative pulmonary complications(During length of hospital stay (about 1 day to a week))

研究者

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Turan

Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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