Intubating Conditions Based On The Ratio Between The Twitch Amplitude And Reference Twitch Amplitude: A Randomized, Prospective, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Maximum T1/Tref ratio associated with excellent intubating conditions
研究概览
简要总结
The purpose of this study is to determine the maximum ratio of the twitch amplitude (T1) to the reference twitch (Tref) amplitude (T1/Tref) that provides excellent intubating conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Age > or = 18 years old
- •Patients willing to participate and provide an integrated, informed consent
排除标准
- •Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
- •Patients with systemic neuromuscular diseases such as myasthenia gravis.
- •Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment requiring dialysis or end-stage liver disease.
- •Patients requiring a rapid sequence induction for airway protection.
- •Patients deemed ineligible for surgery, including pregnancy (as determined by standard of care testing).
研究组 & 干预措施
T1/Tref <0.1
Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude (T1/Tref) <0.1 (deeper level of block)
干预措施: Twitch amplitude <0.1 (Device)
T1/Tref <0.3
Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref <0.3 (intermediate depth of block)
干预措施: Twitch amplitude <0.3 (Other)
T1/Tref <0.5
Participants will be intubated once the ratio of the twitch amplitude to the reference twitch amplitude T1/Tref <0.5 (shallower level of block)
干预措施: Twitch amplitude <0.5 (Other)
结局指标
主要结局
Maximum T1/Tref ratio associated with excellent intubating conditions
时间窗: Baseline
The T1/Tref ratio that leads to the highest proportion of patients being intubated under excellent conditions: T1/Tref \<0.1, T1/Tref \<0.3, or T1/Tref \<0.5
次要结局
- Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.1(Baseline)
- Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.3(Baseline)
- Time to reach specific neuromuscular block level from rocuronium administration to achieving T1/Tref <0.5(Baseline)
- Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.1(Baseline)
- Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.1(Baseline)
- Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.1(Baseline)
- Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.3(Baseline)
- Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.3(Baseline)
- Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.3(Baseline)
- Proportion of patients with excellent intubating conditions at predefined T1/Tred threshold: <0.5(Baseline)
- Proportion of patients with good intubating conditions at predefined T1/Tred threshold: <0.5(Baseline)
- Proportion of patients with poor intubating conditions at predefined T1/Tred threshold: <0.5(Baseline)
研究者
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic