NCT05005390已完成不适用
Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway:A Prospective Randomized and Blinded Trial.
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2021年7月26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
- 147
- 试验地点
- 2
- 主要终点
- Number of Patients With Successful Ventilation
研究概览
简要总结
The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •BMI >30 kg/m2
- •Mallampati class III or IV
- •Requiring general anesthesia
排除标准
- •Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma
- •American Society of Anesthesiologists (ASA)physical status classification ≥IV
- •Emergency surgery
- •Induction requiring rapid sequence for intubation
- •Patients requiring awake intubation
- •Pregnant women
- •Untreated ischemic heart disease
- •Contraindication for mask ventilation
结局指标
主要结局
Number of Patients With Successful Ventilation
时间窗: from start of ventilation to end of ventilation (about 1 minute)
Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.
次要结局
- Peak Inspiratory Airway Pressure Achieved(from start of ventilation to end of ventilation (about 1 minute))
- Dynamic Airway Resistance(from start of ventilation to end of ventilation (about 1 minute))
- Expired Tidal Volume of Ventilation(from start of ventilation to end of ventilation (about 1 minute))
- Satisfaction of the Providers Obtained With Post Ventilation Survey(end of surgery (about 1 hour after start))
研究者
Travis Markham
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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