Do Anti-Snoring Appliances Reduce the Amount of Airway Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Combined Total Number of Airway Interventions During an Anesthetic Sedation Case
研究概览
简要总结
Would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? The investigators will use anti-snoring appliance devices (specifically the FDA approved Zyppah) to attempt to relieve tissue obstructions that cause snoring during sleep. The application of the devices to the body is less invasive than other common intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not designed to be patient specific.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 18-89 years old)
- •Undergoing procedures below the umbilicus requiring anesthetic sedation without an invasive airway
- •a STOP-BANG (survey) score of 2 or greater.
排除标准
- •Patients who are unable to consent
- •Non-English speaking
- •Those requiring general anesthesia.
结局指标
主要结局
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case
时间窗: Through study completion, an average of 1 day
Combined total number of airway interventions during an anesthetic sedation case - including head tilt/rotation, mandible thrust, chin lift, shoulder lift, neck extension or flexion, tongue pull.
次要结局
- Maximum End-tidal CO2(Through study completion, an average of 1 day)
- Heart Rate Minimum(Through study completion, an average of 1 day)
- Maximum Systolic Blood Pressure(Through study completion, an average of 1 day)
- Minimum Systolic Blood Pressure(Through study completion, an average of 1 day)
- Maximum Diastolic Blood Pressure(Through study completion, an average of 1 day)
- Minimum Diastolic Blood Pressure(Through study completion, an average of 1 day)
- Number of Instances SpO2 Value < 92%(Through study completion, an average of 1 day)
- Minimum End-title CO2 in mmHg(Through study completion, an average of 1 day)
- Percent Time During the Case the SpO2 is Below 92%(Through study completion, an average of 1 day)
- Maximum SpO2 Value During the Case(Through study completion, an average of 1 day)
- Minimum SpO2 Value During the Case(Through study completion, an average of 1 day)
- Heart Rate Maximum(Through study completion, an average of 1 day)
- Minimum Mean Blood Pressure(Through study completion, an average of 1 day)
- Reintubation in the Post Anesthesia Care Unit(1 Day)
- Surgical Length of Time(1 day)
- Maximum Mean Blood Pressure(Through study completion, an average of 1 day)
研究者
Mahesh Vaidyanathan
Principal Investigator
Northwestern University